NCT03328559

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 7, 2016

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

October 23, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 1, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2018

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2021

Completed
Last Updated

August 23, 2021

Status Verified

August 1, 2021

Enrollment Period

2.7 years

First QC Date

October 23, 2017

Last Update Submit

August 20, 2021

Conditions

Bronchial Cancer

Outcome Measures

Primary Outcomes (1)

  • numeration of CTC (circulant tumoral cell)

    Day 1

Study Arms (2)

early stage bronchial cancer

OTHER

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

advanced stage bronchial cancer

OTHER

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

Diagnostic Test: ISET® - Isolation by Size of Tumor cells

Interventions

ISET® - Isolation by Size of Tumor cellsDIAGNOSTIC_TEST

early stage bronchial cancer patient will have a blood collection

early stage bronchial cancer

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • refusing participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Groupe Hospitalier Paris Saint Joseph

Paris, Île-de-France Region, 75014, France

Location

MeSH Terms

Conditions

Carcinoma, Bronchogenic

Condition Hierarchy (Ancestors)

Bronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Jean P Tredaniel, Pr

    Fondation Hôpital Saint-Joseph

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2017

First Posted

November 1, 2017

Study Start

March 7, 2016

Primary Completion

November 30, 2018

Study Completion

August 20, 2021

Last Updated

August 23, 2021

Record last verified: 2021-08

Locations

FR(1)