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Identification of Marker of Primary or Acquired Resistance to Anti Tumorous Treatment (MSN)

Primary Purpose

Melanoma, Non Small Cell Lung Cancer, Small Cell Lung Cancer

Status

Unknown status

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Blood sample

Tumorous biopsy

Healthy material sample

About this trial

This is an interventional screening trial for Melanoma

Eligibility Criteria

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

Inclusion Criteria:

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

Exclusion Criteria:

Patients unable to follow the protocol
Consent refusal

Sites / Locations

Gustave Roussy Cancer Campus Grand ParisRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental arm

Arm Description

Blood sample Tumorous biopsy Healthy material sample

Outcomes

Primary Outcome Measures

Mutation rate on tumorous material

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

Secondary Outcome Measures

Full Information

NCT ID

NCT02105168

First Posted

March 31, 2014

Last Updated

June 9, 2016

Sponsor

Gustave Roussy, Cancer Campus, Grand Paris

1. Study Identification

Unique Protocol Identification Number

NCT02105168

Brief Title

Identification of Marker of Primary or Acquired Resistance to Anti Tumorous Treatment

Acronym

MSN

Official Title

Identification of Marker of Primary or Acquired Resistance to Anti Tumorous Treatment in Patients With Lung Cancer or Melanoma

Study Type

Interventional

2. Study Status

Record Verification Date

June 2016

Overall Recruitment Status

Unknown status

Study Start Date

July 2009 (undefined)

Primary Completion Date

July 2019 (Anticipated)

Study Completion Date

July 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Gustave Roussy, Cancer Campus, Grand Paris

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

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

Melanoma, Non Small Cell Lung Cancer, Small Cell Lung Cancer

7. Study Design

Primary Purpose

Screening

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

2200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Experimental arm

Arm Type

Experimental

Arm Description

Blood sample Tumorous biopsy Healthy material sample

Intervention Type

Procedure

Intervention Name(s)

Blood sample

Intervention Description

Optional

Intervention Type

Procedure

Intervention Name(s)

Tumorous biopsy

Intervention Description

Optional

Intervention Type

Procedure

Intervention Name(s)

Healthy material sample

Intervention Description

Optional

Primary Outcome Measure Information:

Title

Mutation rate on tumorous material

Description

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

Time Frame

Assessed at the time of inclusion

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: Patients unable to follow the protocol Consent refusal

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Benjamin Besse, MD

Phone

0142114317

Ext

+33

benjamin.besse@gustaveroussy.fr

First Name & Middle Initial & Last Name or Official Title & Degree

Caroline Robert, MD

Phone

0142114211

Ext

+33

caroline.robert@gustaveroussy.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Benjamin Besse, MD

Organizational Affiliation

Gustave Roussy, Cancer Campus, Grand Paris

Official's Role

Study Chair

Facility Information:

Facility Name

Gustave Roussy Cancer Campus Grand Paris

City

Villejuif

State/Province

Val de Marne

ZIP/Postal Code

94805

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Benjamin Besse, MD

Phone

0142114317

Ext

+33

benjamin.besse@gustaveroussy.fr

First Name & Middle Initial & Last Name & Degree

Caroline Robert, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

34022698

Citation

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.

Results Reference

derived

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Identification of Marker of Primary or Acquired Resistance to Anti Tumorous Treatment

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