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Tissue Sample Collection From Patients With Soft Tissue Sarcoma of the Arms, Hands, Legs, or Feet Treated on Clinial Trial CRUK-VORTEX

Primary Purpose

Sarcoma

Status
Unknown status
Phase
Locations
United Kingdom
Study Type
Observational
Intervention
microarray analysis
molecular diagnostic method
biologic sample preservation procedure
Sponsored by
The Christie NHS Foundation Trust
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Sarcoma focused on measuring recurrent adult soft tissue sarcoma, stage I adult soft tissue sarcoma, stage II adult soft tissue sarcoma, stage III adult soft tissue sarcoma, adult synovial sarcoma, adult angiosarcoma, adult epithelioid sarcoma, adult extraskeletal chondrosarcoma, adult leiomyosarcoma, adult liposarcoma, adult malignant fibrous histiocytoma, adult malignant hemangiopericytoma, adult malignant mesenchymoma, adult fibrosarcoma, adult neurofibrosarcoma

Eligibility Criteria

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

DISEASE CHARACTERISTICS:

  • Histologically confirmed soft tissue sarcoma
  • Receiving treatment on clinical trial CRUK-VORTEX
  • Underwent surgery to remove the tumor no more than 3 months ago

PATIENT CHARACTERISTICS:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3 months after completion of study treatment
  • No other major medical illness that would preclude study treatment
  • No other prior or concurrent malignancy except adequately treated nonmelanoma carcinoma of the skin or in situ carcinoma of the cervix

PRIOR CONCURRENT THERAPY:

  • No prior radiotherapy to the local site
  • No prior neoadjuvant or adjuvant chemotherapy

Sites / Locations

  • Queen Elizabeth Hospital at University Hospital of Birmingham NHS TrustRecruiting
  • Royal Orthopedic Hospital NHS TrustRecruiting
  • Bristol Haematology and Oncology CentreRecruiting
  • Gloucestershire Oncology Centre at Cheltenham General HospitalRecruiting
  • Royal National Orthopaedic Hospital NHS TrustRecruiting
  • Middlesex HospitalRecruiting
  • Christie HospitalRecruiting
  • Nottingham City HospitalRecruiting
  • Cancer Research Centre at Weston Park HospitalRecruiting
  • Robert Jones and Agnes Hunt Orthopaedic and District Hospital NHS TrustRecruiting
  • Beatson West of Scotland Cancer CentreRecruiting
  • Glan Clwyd HospitalRecruiting

Outcomes

Primary Outcome Measures

Increased likelihood of distant metastases

Secondary Outcome Measures

Full Information

First Posted
May 9, 2009
Last Updated
August 23, 2013
Sponsor
The Christie NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT00900211
Brief Title
Tissue Sample Collection From Patients With Soft Tissue Sarcoma of the Arms, Hands, Legs, or Feet Treated on Clinial Trial CRUK-VORTEX
Official Title
VORTEX-BIOBANK: Prospective Sample Collection for the VORTEX Randomised Radiotherapy Trial in Patients With Extremity Soft Tissue Sarcoma [VORTEX BIOBANK]
Study Type
Observational

2. Study Status

Record Verification Date
April 2008
Overall Recruitment Status
Unknown status
Study Start Date
August 2007 (undefined)
Primary Completion Date
March 2012 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
The Christie NHS Foundation Trust

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Collecting and storing samples of tumor tissue from patients with soft tissue sarcoma to test in the laboratory may help the study of cancer in the future. PURPOSE: This laboratory is collecting tissue samples from patients with soft tissue sarcoma of the arms, hands, legs, or feet treated on clinical trial CRUK-VORTEX.
Detailed Description
OBJECTIVES: Determine early in the course of treatment which patients treated on clinical trial CRUK-VORTEX have an increased likelihood of distant metastases so as to highlight individuals who might benefit from early adjuvant systemic therapy. OUTLINE: This is a multicenter study. Tumour and normal tissue samples will be taken at the time of surgery during treatment on clinical trial CRUK-VORTEXand preserved for future microarray analyses. Tissue microarrays will be produced from both tumor and normal tissues. Blood samples will be collected for future DNA analysis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoma
Keywords
recurrent adult soft tissue sarcoma, stage I adult soft tissue sarcoma, stage II adult soft tissue sarcoma, stage III adult soft tissue sarcoma, adult synovial sarcoma, adult angiosarcoma, adult epithelioid sarcoma, adult extraskeletal chondrosarcoma, adult leiomyosarcoma, adult liposarcoma, adult malignant fibrous histiocytoma, adult malignant hemangiopericytoma, adult malignant mesenchymoma, adult fibrosarcoma, adult neurofibrosarcoma

7. Study Design

Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Genetic
Intervention Name(s)
microarray analysis
Intervention Type
Genetic
Intervention Name(s)
molecular diagnostic method
Intervention Type
Other
Intervention Name(s)
biologic sample preservation procedure
Primary Outcome Measure Information:
Title
Increased likelihood of distant metastases

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed soft tissue sarcoma Receiving treatment on clinical trial CRUK-VORTEX Underwent surgery to remove the tumor no more than 3 months ago PATIENT CHARACTERISTICS: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 3 months after completion of study treatment No other major medical illness that would preclude study treatment No other prior or concurrent malignancy except adequately treated nonmelanoma carcinoma of the skin or in situ carcinoma of the cervix PRIOR CONCURRENT THERAPY: No prior radiotherapy to the local site No prior neoadjuvant or adjuvant chemotherapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine West
Organizational Affiliation
The Christie NHS Foundation Trust
Official's Role
Study Chair
Facility Information:
Facility Name
Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust
City
Birmingham
State/Province
England
ZIP/Postal Code
B15 2TH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
44-121-472-1311
Facility Name
Royal Orthopedic Hospital NHS Trust
City
Birmingham
State/Province
England
ZIP/Postal Code
B31 2AP
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
44-121-685-4019
Facility Name
Bristol Haematology and Oncology Centre
City
Bristol
State/Province
England
ZIP/Postal Code
BS2 8ED
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
44-117-928-2417
Facility Name
Gloucestershire Oncology Centre at Cheltenham General Hospital
City
Cheltenham
State/Province
England
ZIP/Postal Code
GL53 7AN
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
44-1242-222-222
Facility Name
Royal National Orthopaedic Hospital NHS Trust
City
Cheltenham
State/Province
England
ZIP/Postal Code
GL53 7AN
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
44-020-8954-2300
Facility Name
Middlesex Hospital
City
London
State/Province
England
ZIP/Postal Code
W1T 3AA
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
44-0207-380-9087
Facility Name
Christie Hospital
City
Manchester
State/Province
England
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
44-161-446-3341
Email
Catharine.west@manchester.ac.uk
Facility Name
Nottingham City Hospital
City
Nottingham
State/Province
England
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
44-115-969-1169
Facility Name
Cancer Research Centre at Weston Park Hospital
City
Sheffield
State/Province
England
ZIP/Postal Code
S1O 2SJ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
44-114-226-5208
Facility Name
Robert Jones and Agnes Hunt Orthopaedic and District Hospital NHS Trust
City
Shropshire
State/Province
England
ZIP/Postal Code
SY10 7AG
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
44-0161-446-3341
Facility Name
Beatson West of Scotland Cancer Centre
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G12 0YN
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
44-141-301-7000
Facility Name
Glan Clwyd Hospital
City
Rhyl, Denbighshire
State/Province
Wales
ZIP/Postal Code
LL 18 5UJ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
44-1745-583-910

12. IPD Sharing Statement

Learn more about this trial

Tissue Sample Collection From Patients With Soft Tissue Sarcoma of the Arms, Hands, Legs, or Feet Treated on Clinial Trial CRUK-VORTEX

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