NCT02105168

Brief Summary

Lung Cancer and melanoma relapsed frequently whereas its very sensitive to treatment such as chemotherapy or radiotherapy. The purpose of this study is to have a better understanding of why those patients are relapsing using next generation sequencing to identify rare mutations and assessed their predictive value.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
2,200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

July 1, 2009

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

March 31, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 7, 2014

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

June 10, 2016

Status Verified

June 1, 2016

Enrollment Period

10 years

First QC Date

March 31, 2014

Last Update Submit

June 9, 2016

Conditions

MelanomaNon Small Cell Lung CancerSmall Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • Mutation rate on tumorous material

    Assessed at the time of inclusion using tumorous material used for diagnosis

    Assessed at the time of inclusion

Study Arms (1)

Experimental arm

EXPERIMENTAL

Blood sample Tumorous biopsy Healthy material sample

Procedure: Blood sampleProcedure: Tumorous biopsyProcedure: Healthy material sample

Interventions

Blood samplePROCEDURE

Optional

Experimental arm
Tumorous biopsyPROCEDURE

Optional

Experimental arm
Healthy material samplePROCEDURE

Optional

Experimental arm

Eligibility Criteria

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

You may qualify if:

  • Cytological or histological diagnosis of SCLC, NSCLC or melanoma
  • Patients age \>/= 18 years old
  • Indication of treatment using platinum salts for lung cancer except for patient with NSCLC treated by surgery for whom platinum salts is not indicated
  • If a biopsy is proposed, lesion lust be easily accessible
  • Signed informed consent

You may not qualify if:

  • Patients unable to follow the protocol
  • Consent refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gustave Roussy Cancer Campus Grand Paris

Villejuif, Val de Marne, 94805, France

RECRUITING

Related Publications (1)

  • Mezquita L, Preeshagul I, Auclin E, Saravia D, Hendriks L, Rizvi H, Park W, Nadal E, Martin-Romano P, Ruffinelli JC, Ponce S, Audigier-Valette C, Carnio S, Blanc-Durand F, Bironzo P, Tabbo F, Reale ML, Novello S, Hellmann MD, Sawan P, Girshman J, Plodkowski AJ, Zalcman G, Majem M, Charrier M, Naigeon M, Rossoni C, Mariniello A, Paz-Ares L, Dingemans AM, Planchard D, Cozic N, Cassard L, Lopes G, Chaput N, Arbour K, Besse B. Predicting immunotherapy outcomes under therapy in patients with advanced NSCLC using dNLR and its early dynamics. Eur J Cancer. 2021 Jul;151:211-220. doi: 10.1016/j.ejca.2021.03.011. Epub 2021 May 19.

    PMID: 34022698DERIVED

MeSH Terms

Conditions

MelanomaCarcinoma, Non-Small-Cell LungSmall Cell Lung Carcinoma

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue DiseasesCarcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Benjamin Besse, MD

    Gustave Roussy, Cancer Campus, Grand Paris

    STUDY CHAIR

Central Study Contacts

Benjamin Besse, MD

CONTACT

0142114317benjamin.besse@gustaveroussy.fr

Caroline Robert, MD

CONTACT

0142114211caroline.robert@gustaveroussy.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2014

First Posted

April 7, 2014

Study Start

July 1, 2009

Primary Completion

July 1, 2019

Study Completion

July 1, 2019

Last Updated

June 10, 2016

Record last verified: 2016-06

Locations

FR(1)