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Kinetics of Circulating Tumoral Cells in Bronchial Primitive Cancer

Primary Purpose

Bronchial Cancer

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
ISET® - Isolation by Size of Tumor cells
ISET® - Isolation by Size of Tumor cells
Sponsored by
Fondation Hôpital Saint-Joseph
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Bronchial Cancer

Eligibility Criteria

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

Inclusion Criteria:

  • patients with non-small cell lung cancer
  • accepting participation

Exclusion Criteria:

  • refusing participation

Sites / Locations

  • Groupe Hospitalier Paris Saint Joseph

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

early stage bronchial cancer

advanced stage bronchial cancer

Arm Description

Early stage which can benefit from a surgical resection. A taking will be made in preoperative then in every consultation of follow-up after the intervention

Patients locally moved forward or at a metastatic stage handled by chemotherapy

Outcomes

Primary Outcome Measures

numeration of CTC (circulant tumoral cell)

Secondary Outcome Measures

Full Information

First Posted
October 23, 2017
Last Updated
August 20, 2021
Sponsor
Fondation Hôpital Saint-Joseph
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1. Study Identification

Unique Protocol Identification Number
NCT03328559
Brief Title
Kinetics of Circulating Tumoral Cells in Bronchial Primitive Cancer
Official Title
Kinetics of Circulating Tumoral Cells in Bronchial Primitive Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
March 7, 2016 (Actual)
Primary Completion Date
November 30, 2018 (Actual)
Study Completion Date
August 20, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondation Hôpital Saint-Joseph

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The pronostic value of Circulating Tumoral Cells(CTC) 's dosage by the method ISET® (tumoral cell isolation by size) in patients with bronchial cancer was previously demonstrated. However, no kinetic study was ever realized to study the value of the CTC as predictive indicator of answer to the therapy. This project plans to study patients in an early stage and patients at advance stage locally moved forward or metastatic of the disease by evaluation of the presence and the number of CTC before every cure. This collaborative and original study should allow to refine the diagnoses of answer and to plan the possible relapses what would allow a premature institution of the treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchial Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
early stage bronchial cancer
Arm Type
Other
Arm Description
Early stage which can benefit from a surgical resection. A taking will be made in preoperative then in every consultation of follow-up after the intervention
Arm Title
advanced stage bronchial cancer
Arm Type
Other
Arm Description
Patients locally moved forward or at a metastatic stage handled by chemotherapy
Intervention Type
Diagnostic Test
Intervention Name(s)
ISET® - Isolation by Size of Tumor cells
Intervention Description
early stage bronchial cancer patient will have a blood collection
Intervention Type
Diagnostic Test
Intervention Name(s)
ISET® - Isolation by Size of Tumor cells
Intervention Description
advanced stage bronchial cancer patient will have a blood collection
Primary Outcome Measure Information:
Title
numeration of CTC (circulant tumoral cell)
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients with non-small cell lung cancer accepting participation Exclusion Criteria: refusing participation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean P Tredaniel, Pr
Organizational Affiliation
Fondation Hôpital Saint-Joseph
Official's Role
Principal Investigator
Facility Information:
Facility Name
Groupe Hospitalier Paris Saint Joseph
City
Paris
State/Province
Ile-de-France
ZIP/Postal Code
75014
Country
France

12. IPD Sharing Statement

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Kinetics of Circulating Tumoral Cells in Bronchial Primitive Cancer

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