Kinetics of Circulating Tumoral Cells in Bronchial Primitive Cancer

August 20, 2021 updated by: Groupe Hospitalier Paris Saint Joseph

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Ile-de-France
      • Paris, Ile-de-France, France, 75014
        • Groupe hospitalier Paris saint Joseph

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • refusing participation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: early stage bronchial cancer
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
Diagnostic test: ISET® - Isolation by Size of Tumor cells
early stage bronchial cancer patient will have a blood collection
Diagnostic test: ISET® - Isolation by Size of Tumor cells
advanced stage bronchial cancer patient will have a blood collection
Other: advanced stage bronchial cancer
Patients locally moved forward or at a metastatic stage handled by chemotherapy
Diagnostic test: ISET® - Isolation by Size of Tumor cells
early stage bronchial cancer patient will have a blood collection
Diagnostic test: ISET® - Isolation by Size of Tumor cells
advanced stage bronchial cancer patient will have a blood collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
numeration of CTC (circulant tumoral cell)
Time Frame: Day 1
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Groupe Hospitalier Paris Saint Joseph

Investigators

  • Principal Investigator: Jean P Tredaniel, Pr, Groupe hospitalier Paris saint Joseph

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 7, 2016

Primary Completion (Actual)

November 30, 2018

Study Completion (Actual)

August 20, 2021

Study Registration Dates

First Submitted

October 23, 2017

First Submitted That Met QC Criteria

October 30, 2017

First Posted (Actual)

November 1, 2017

Study Record Updates

Last Update Posted (Actual)

August 23, 2021

Last Update Submitted That Met QC Criteria

August 20, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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