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Non-small Cell Lung Cancer Registry

Primary Purpose

Non-Small-Cell Lung Cancer, Pleural Effusion, Malignant

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
zoledronic acid
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Small-Cell Lung Cancer focused on measuring Lung Cancer, Bone Metastases, Bone Markers, NTX, zoledronic acid, Registry, Unresectable Stage IV Non Small-cell Lung Cancer (NSCLC), Unresectable Stage IIIB NSCLC with Pleural Effusion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age greater than or equal to 18 years Histologically confirmed NSCLC (squamous cell carcinoma, adenocarcinoma, large cell carcinoma). Unresectable Stage IIIB with pleural effusion or stage IV NSCLC ECOG performance status of 0 or 1 Exclusion Criteria: Patients who received an IV bisphosphonate (e.g.pamidronate; zoledronic acid) Patients who received an oral bisphosphonate therapy in the 6 months prior to screening (alendronate; etidronate; risedronate; tiludronate; ibandronate) Patients who are currently receiving any investigational drugs that are suspected to have renal toxicity and/or are excreted by the kidneys Known clinically significant hypersensitivity to zoledronic acid or other bisphosphonates or any of the excipients in the formulation of zoledronic acid (mannitol, sodium citrate) Abnormal renal function or creatinine clearance Unstable brain metastasis Women of childbearing potential not using a medically recognized form of contraception, as well as women who are breastfeeding Patients with nonmalignant conditions which would confound the evaluation of the primary endpoint, impair tolerance of therapy, or prevent compliance to the protocol

Sites / Locations

  • Birmingham Hematology and Oncology Associates
  • Hembree Cancer Center-St. Edward Mercy Medical Center
  • Pacific Cancer Medical Center Inc.
  • Bay Area Cancer Research Group
  • Fresno Hem/Onc Medical Group
  • Beaver Med Group
  • Redwood Regional Medical Group
  • Stockton Hem. Onc.
  • Rocky Mountain Cancer Centers
  • Front Range Cancer Specialists
  • Greeley Medical Clinic
  • Western Hematology/Oncology
  • Hematology Oncology PC
  • Christiana Care Health Services
  • Gainesville Hematology Oncology Associates
  • Baptist Cancer Institute
  • Center for Cancer Care & Research
  • Lake Heart & Cancer Center
  • Melbourne Internal Medicine Assoc (MIMA) Century Research
  • Pasco Pinellas Cancer Center
  • Ocala Oncology Center
  • Mid- Florida Hematology & Oncology Centers, PA
  • Space Coast Medical
  • Vero Beach Hematology/Oncology
  • Hematology & Oncology of N.E. GA
  • Augusta Onc. Associates
  • Suburban Hematology-Oncology
  • Regional Cancer Center
  • The Cancer Institute at Alexian Brothers
  • Lekha Babu M.D Ltd.
  • Joliet Oncology Hematology Associates, Ltd
  • LaGrange Oncology Associates
  • Northwest Medical Specialists
  • Midwest Cancer Research Group
  • Medical Consultants, PC
  • Kentuckiana Cancer Center, PLLC
  • W. Kentucky Hematology's Oncology Group, PSC
  • Cabrini Center for Cancer Care
  • Louisiana Oncology Associates
  • Hematology and Oncology Specialists
  • Highland Clinic, APMC
  • Sinai Hospital
  • Maryland Hematology/Oncology Associates
  • David H. Smith, MD
  • Oncology-Hematology Associates, PA
  • Maryland Oncology
  • St. Joseph Medical Center
  • Caritas Holy Family Hospital
  • Fallon Clinic
  • Henry Ford Medical Center
  • Singh & Arora Hematology/Oncology
  • Hubert Humphrey Cancer Center
  • Heartland Hematology/Oncology Associates Inc.
  • St. Joseph Onocology, Inc.
  • University Hematology Oncology, Inc.
  • St. John's Mercy Medical Center
  • Sierra Nevada Oncology Care
  • Nevada Cancer Center
  • US Oncology
  • Center For Cancer & Hematologic Disease
  • HOANNJ/Carol G. Simon Cancer Center
  • Medical Hematology/Oncology
  • Hematology-Oncology Associates of CNY
  • Huntington Medical Group
  • Broome Oncology
  • Kin Yui Lam, MD
  • Alamance Regional Medical Ctr. Cancer Ctr.
  • Raleigh Hematology Oncology Associates
  • Summa Health System
  • OHCI
  • Mukesh Bhatt, MD
  • Lawrence M. Stallings, MD, LLC
  • M. Farouk Kanaa, MD, Inc.
  • Cancer Treatment Center
  • Oncology-Hematology of Lehigh Valley PC
  • Paul V. Woolley MD PC
  • Chester County Hematology/Oncology Services
  • South Carolina Oncology Assoc., PA
  • Palmetto Hematology Oncology, P.C
  • Associates in Oncology and Hematology
  • The Family Cancer Center, PLLC
  • McLeod Cancer & Blood Center
  • Kingsport Hematology-Oncology
  • Eastern Connecticut Hematology/Oncology
  • Oncology Hematology of South Florida
  • The West Clinic
  • Southwest Regional Cancer Center
  • St. Joseph Regional Cancer Ctr.
  • Coastal Bend Cancer Center
  • Center for Oncology Research and Treatment, PA
  • Oncology Consultants P.A.
  • South Texas Oncology & Hematology
  • Tyler Cancer Center
  • Cancer Outreach
  • Lynchburg Oncology
  • Virginia Cancer Institute
  • Oncology/Hematology Association of SW VA
  • Western WA Med. Grp. Oncology
  • Western Washington Oncology
  • Swedish Health Services
  • Oncology Alliance, S.C.

Outcomes

Primary Outcome Measures

Group 1: Time to the first occurrence of an skeletal related event (SRE) in unresectable stage IIIB/IV NSCLC patients with bone metastases
Group 2: Observational

Secondary Outcome Measures

Patients with an SRE will be evaluated for:
Time from stage IIIB/IV NSCLC diagnosis to progression to bone
Time from bone metastasis diagnosis to presentation of clinical symptoms of skeletal complications
The effect of serum NTX levels on the development of skeletal events (SREs), and
Overall survival
Group 2: Obervational

Full Information

First Posted
December 15, 2004
Last Updated
November 20, 2009
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00099541
Brief Title
Non-small Cell Lung Cancer Registry
Official Title
A Dual-Cohort, Prospective, Observational Study of Unresectable Stage IIIB/IV Non-Small Cell Lung Cancer Patients With and Without Bone Metastasis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary
This trial will evaluate two separate groups of patients with stage IIIB/IV non-small cell lung cancer. The objective of Group 1 is to investigate an FDA-approved drug in stage IIIB/IV non-small cell lung cancer patients that has spread to the bones. The objective of Group 2 is to see if a blood test can be used to predict when cancer-related bone lesions develop. This trial is seeking patients 18 years or older that have been diagnosed with Stage IIIB or Stage IV non-small cell lung cancer that cannot be treated by surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small-Cell Lung Cancer, Pleural Effusion, Malignant
Keywords
Lung Cancer, Bone Metastases, Bone Markers, NTX, zoledronic acid, Registry, Unresectable Stage IV Non Small-cell Lung Cancer (NSCLC), Unresectable Stage IIIB NSCLC with Pleural Effusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
300 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
zoledronic acid
Primary Outcome Measure Information:
Title
Group 1: Time to the first occurrence of an skeletal related event (SRE) in unresectable stage IIIB/IV NSCLC patients with bone metastases
Title
Group 2: Observational
Secondary Outcome Measure Information:
Title
Patients with an SRE will be evaluated for:
Title
Time from stage IIIB/IV NSCLC diagnosis to progression to bone
Title
Time from bone metastasis diagnosis to presentation of clinical symptoms of skeletal complications
Title
The effect of serum NTX levels on the development of skeletal events (SREs), and
Title
Overall survival
Title
Group 2: Obervational

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age greater than or equal to 18 years Histologically confirmed NSCLC (squamous cell carcinoma, adenocarcinoma, large cell carcinoma). Unresectable Stage IIIB with pleural effusion or stage IV NSCLC ECOG performance status of 0 or 1 Exclusion Criteria: Patients who received an IV bisphosphonate (e.g.pamidronate; zoledronic acid) Patients who received an oral bisphosphonate therapy in the 6 months prior to screening (alendronate; etidronate; risedronate; tiludronate; ibandronate) Patients who are currently receiving any investigational drugs that are suspected to have renal toxicity and/or are excreted by the kidneys Known clinically significant hypersensitivity to zoledronic acid or other bisphosphonates or any of the excipients in the formulation of zoledronic acid (mannitol, sodium citrate) Abnormal renal function or creatinine clearance Unstable brain metastasis Women of childbearing potential not using a medically recognized form of contraception, as well as women who are breastfeeding Patients with nonmalignant conditions which would confound the evaluation of the primary endpoint, impair tolerance of therapy, or prevent compliance to the protocol
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
L. Lacerna, MD
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Chair
Facility Information:
Facility Name
Birmingham Hematology and Oncology Associates
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
Hembree Cancer Center-St. Edward Mercy Medical Center
City
Fort Smith
State/Province
Arkansas
ZIP/Postal Code
72903
Country
United States
Facility Name
Pacific Cancer Medical Center Inc.
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Bay Area Cancer Research Group
City
Concord
State/Province
California
ZIP/Postal Code
94520
Country
United States
Facility Name
Fresno Hem/Onc Medical Group
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Beaver Med Group
City
Highland
State/Province
California
ZIP/Postal Code
92346
Country
United States
Facility Name
Redwood Regional Medical Group
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95403
Country
United States
Facility Name
Stockton Hem. Onc.
City
Stockton
State/Province
California
ZIP/Postal Code
95204
Country
United States
Facility Name
Rocky Mountain Cancer Centers
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Front Range Cancer Specialists
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80524
Country
United States
Facility Name
Greeley Medical Clinic
City
Greeley
State/Province
Colorado
ZIP/Postal Code
80631
Country
United States
Facility Name
Western Hematology/Oncology
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80215
Country
United States
Facility Name
Hematology Oncology PC
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06902
Country
United States
Facility Name
Christiana Care Health Services
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
Gainesville Hematology Oncology Associates
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32605
Country
United States
Facility Name
Baptist Cancer Institute
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
Center for Cancer Care & Research
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33805
Country
United States
Facility Name
Lake Heart & Cancer Center
City
Leesburg
State/Province
Florida
ZIP/Postal Code
34748
Country
United States
Facility Name
Melbourne Internal Medicine Assoc (MIMA) Century Research
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32901
Country
United States
Facility Name
Pasco Pinellas Cancer Center
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
Facility Name
Ocala Oncology Center
City
Ocala
State/Province
Florida
ZIP/Postal Code
34474
Country
United States
Facility Name
Mid- Florida Hematology & Oncology Centers, PA
City
Orange City
State/Province
Florida
ZIP/Postal Code
32763
Country
United States
Facility Name
Space Coast Medical
City
Titusville
State/Province
Florida
ZIP/Postal Code
32796
Country
United States
Facility Name
Vero Beach Hematology/Oncology
City
Vero Beach
State/Province
Florida
ZIP/Postal Code
32960
Country
United States
Facility Name
Hematology & Oncology of N.E. GA
City
Athens
State/Province
Georgia
ZIP/Postal Code
30607
Country
United States
Facility Name
Augusta Onc. Associates
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30901
Country
United States
Facility Name
Suburban Hematology-Oncology
City
Snellville
State/Province
Georgia
ZIP/Postal Code
30078
Country
United States
Facility Name
Regional Cancer Center
City
Danville
State/Province
Illinois
ZIP/Postal Code
61832
Country
United States
Facility Name
The Cancer Institute at Alexian Brothers
City
Elk Grove Village
State/Province
Illinois
ZIP/Postal Code
60007
Country
United States
Facility Name
Lekha Babu M.D Ltd.
City
Flossmoor
State/Province
Illinois
ZIP/Postal Code
60422
Country
United States
Facility Name
Joliet Oncology Hematology Associates, Ltd
City
Joliet
State/Province
Illinois
ZIP/Postal Code
60435
Country
United States
Facility Name
LaGrange Oncology Associates
City
LaGrange
State/Province
Illinois
ZIP/Postal Code
60525
Country
United States
Facility Name
Northwest Medical Specialists
City
Niles
State/Province
Illinois
ZIP/Postal Code
60714
Country
United States
Facility Name
Midwest Cancer Research Group
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60077
Country
United States
Facility Name
Medical Consultants, PC
City
Muncie
State/Province
Indiana
ZIP/Postal Code
47303
Country
United States
Facility Name
Kentuckiana Cancer Center, PLLC
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
W. Kentucky Hematology's Oncology Group, PSC
City
Paducah
State/Province
Kentucky
ZIP/Postal Code
42003
Country
United States
Facility Name
Cabrini Center for Cancer Care
City
Alexandria
State/Province
Louisiana
ZIP/Postal Code
71301
Country
United States
Facility Name
Louisiana Oncology Associates
City
Lafayette
State/Province
Louisiana
ZIP/Postal Code
70506
Country
United States
Facility Name
Hematology and Oncology Specialists
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Highland Clinic, APMC
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71105
Country
United States
Facility Name
Sinai Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21215
Country
United States
Facility Name
Maryland Hematology/Oncology Associates
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21237
Country
United States
Facility Name
David H. Smith, MD
City
Chestertown
State/Province
Maryland
ZIP/Postal Code
21620
Country
United States
Facility Name
Oncology-Hematology Associates, PA
City
Clinton
State/Province
Maryland
ZIP/Postal Code
20735
Country
United States
Facility Name
Maryland Oncology
City
Columbia
State/Province
Maryland
ZIP/Postal Code
21044
Country
United States
Facility Name
St. Joseph Medical Center
City
Towson
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
Caritas Holy Family Hospital
City
Methuen
State/Province
Massachusetts
ZIP/Postal Code
01844
Country
United States
Facility Name
Fallon Clinic
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States
Facility Name
Henry Ford Medical Center
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Singh & Arora Hematology/Oncology
City
Flint
State/Province
Michigan
ZIP/Postal Code
48532
Country
United States
Facility Name
Hubert Humphrey Cancer Center
City
Robbinsdale
State/Province
Minnesota
ZIP/Postal Code
55442
Country
United States
Facility Name
Heartland Hematology/Oncology Associates Inc.
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64118
Country
United States
Facility Name
St. Joseph Onocology, Inc.
City
St. Joseph
State/Province
Missouri
ZIP/Postal Code
64507
Country
United States
Facility Name
University Hematology Oncology, Inc.
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
St. John's Mercy Medical Center
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Sierra Nevada Oncology Care
City
Carson City
State/Province
Nevada
ZIP/Postal Code
89703
Country
United States
Facility Name
Nevada Cancer Center
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Facility Name
US Oncology
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Facility Name
Center For Cancer & Hematologic Disease
City
Cherry Hill
State/Province
New Jersey
ZIP/Postal Code
08003
Country
United States
Facility Name
HOANNJ/Carol G. Simon Cancer Center
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Facility Name
Medical Hematology/Oncology
City
Somerset
State/Province
New Jersey
ZIP/Postal Code
08873
Country
United States
Facility Name
Hematology-Oncology Associates of CNY
City
East Syracuse
State/Province
New York
ZIP/Postal Code
13057
Country
United States
Facility Name
Huntington Medical Group
City
Huntington Station
State/Province
New York
ZIP/Postal Code
11746
Country
United States
Facility Name
Broome Oncology
City
Johnson City
State/Province
New York
ZIP/Postal Code
13790
Country
United States
Facility Name
Kin Yui Lam, MD
City
New York
State/Province
New York
ZIP/Postal Code
10013
Country
United States
Facility Name
Alamance Regional Medical Ctr. Cancer Ctr.
City
Burlington
State/Province
North Carolina
ZIP/Postal Code
27215
Country
United States
Facility Name
Raleigh Hematology Oncology Associates
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
Facility Name
Summa Health System
City
Akron
State/Province
Ohio
ZIP/Postal Code
44304
Country
United States
Facility Name
OHCI
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Mukesh Bhatt, MD
City
Medina
State/Province
Ohio
ZIP/Postal Code
44256
Country
United States
Facility Name
Lawrence M. Stallings, MD, LLC
City
Wooster
State/Province
Ohio
ZIP/Postal Code
44691
Country
United States
Facility Name
M. Farouk Kanaa, MD, Inc.
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
Facility Name
Cancer Treatment Center
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74133
Country
United States
Facility Name
Oncology-Hematology of Lehigh Valley PC
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18015
Country
United States
Facility Name
Paul V. Woolley MD PC
City
Johnstown
State/Province
Pennsylvania
ZIP/Postal Code
15905
Country
United States
Facility Name
Chester County Hematology/Oncology Services
City
West Chester
State/Province
Pennsylvania
ZIP/Postal Code
19380
Country
United States
Facility Name
South Carolina Oncology Assoc., PA
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29201
Country
United States
Facility Name
Palmetto Hematology Oncology, P.C
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303-3041
Country
United States
Facility Name
Associates in Oncology and Hematology
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
The Family Cancer Center, PLLC
City
Collierville
State/Province
Tennessee
ZIP/Postal Code
38017
Country
United States
Facility Name
McLeod Cancer & Blood Center
City
Johnson City
State/Province
Tennessee
ZIP/Postal Code
37604
Country
United States
Facility Name
Kingsport Hematology-Oncology
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
Eastern Connecticut Hematology/Oncology
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Oncology Hematology of South Florida
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
The West Clinic
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Southwest Regional Cancer Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
St. Joseph Regional Cancer Ctr.
City
Bryan
State/Province
Texas
ZIP/Postal Code
77802
Country
United States
Facility Name
Coastal Bend Cancer Center
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78404
Country
United States
Facility Name
Center for Oncology Research and Treatment, PA
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Oncology Consultants P.A.
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Facility Name
South Texas Oncology & Hematology
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78258
Country
United States
Facility Name
Tyler Cancer Center
City
Tyler
State/Province
Texas
ZIP/Postal Code
75702
Country
United States
Facility Name
Cancer Outreach
City
Abingdon
State/Province
Virginia
ZIP/Postal Code
24211
Country
United States
Facility Name
Lynchburg Oncology
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24501
Country
United States
Facility Name
Virginia Cancer Institute
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23230
Country
United States
Facility Name
Oncology/Hematology Association of SW VA
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24104
Country
United States
Facility Name
Western WA Med. Grp. Oncology
City
Everett
State/Province
Washington
ZIP/Postal Code
98201
Country
United States
Facility Name
Western Washington Oncology
City
Lacey
State/Province
Washington
ZIP/Postal Code
98503
Country
United States
Facility Name
Swedish Health Services
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Oncology Alliance, S.C.
City
Glendale
State/Province
Wisconsin
ZIP/Postal Code
53212
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.novartisclinicaltrials.com
Description
Visit NovartisClinicalTrials.com: Pre-qualify for a trial, and view a list of trials and participating study centers.

Learn more about this trial

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