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Study of the Biological Mechanisms Associated With the Immunogenicity in Anaplastic Large Cell Lymphoma ( ALCL ) ALK + (Immuno ALCL)

Primary Purpose

ALCL

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood sample
Sponsored by
Gustave Roussy, Cancer Campus, Grand Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for ALCL

Eligibility Criteria

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

Inclusion Criteria:

  • Every patients treated according to COPAD-IGR, HM 89,91 and 97 and ALCL99 protocols and included in related studies
  • Clinical data registered in SFCE database
  • Signed consent form

Exclusion Criteria:

  • No ALK expression on tumour
  • No consent signed

Sites / Locations

  • Gustave Roussy

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients treated for anaplastic large cell lymphoma ( ALCL )

Arm Description

Outcomes

Primary Outcome Measures

Number of single nucleotide polymorphisms in main immunogenicity genes using VERACODE ILLUMINA technology

Secondary Outcome Measures

Full Information

First Posted
September 7, 2016
Last Updated
May 24, 2022
Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
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1. Study Identification

Unique Protocol Identification Number
NCT02902874
Brief Title
Study of the Biological Mechanisms Associated With the Immunogenicity in Anaplastic Large Cell Lymphoma ( ALCL ) ALK +
Acronym
Immuno ALCL
Official Title
Study of the Biological Mechanisms Associated With the Immunogenicity in Anaplastic Large Cell Lymphoma ( ALCL ) ALK +
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
April 21, 2010 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gustave Roussy, Cancer Campus, Grand Paris

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To study the correlation between the polymorphism of the main immunity genes and progression-free survival in ALCL of the child.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
185 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients treated for anaplastic large cell lymphoma ( ALCL )
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Blood sample
Primary Outcome Measure Information:
Title
Number of single nucleotide polymorphisms in main immunogenicity genes using VERACODE ILLUMINA technology
Time Frame
up to 78 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Every patients treated according to COPAD-IGR, HM 89,91 and 97 and ALCL99 protocols and included in related studies Clinical data registered in SFCE database Signed consent form Exclusion Criteria: No ALK expression on tumour No consent signed
Facility Information:
Facility Name
Gustave Roussy
City
Villejuif
State/Province
Val De Marne
ZIP/Postal Code
94805
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Study of the Biological Mechanisms Associated With the Immunogenicity in Anaplastic Large Cell Lymphoma ( ALCL ) ALK +

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