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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04349293
Other study ID # 2016-A00732-49
Secondary ID 2015/2331
Status Recruiting
Phase N/A
First received
Last updated
Start date September 8, 2016
Est. completion date September 2021

Study information

Verified date April 2020
Source Gustave Roussy, Cancer Campus, Grand Paris
Contact Laurence ZITVOGEL, MD, PhD
Phone 0142114211
Email laurence.zitvogel@gustaveroussy.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Multicentric interventional prospective study with collection of biological samples as part of a routine care research


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date September 2021
Est. primary completion date September 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. Age greater than or equal to 18 years.

2. Male and female sex.

3. Any patient with cancer (see list in the body of the protocol) requiring treatment by surgical resection and / or who will start treatment with mAb or BiTE.

4. Patient information and signed informed consent.

5. Subjects affiliated (or beneficiary) to a social security scheme

Patients treated for immune complications by immunosuppressants may be included (corticosteroids, etc.).

Exclusion Criteria:

1. History of severe systemic autoimmune disease.

2. Pregnant or breastfeeding patient

3. Impossibility or refusal to sign informed consent

4. Patient under guardianship or curatorship, or deprived of liberty by a judicial or administrative decision

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Tissue sampling
Collection of a sample of tumor tissue and a sample of adjacent or counter lateral healthy tissue (if possible) from the surgical room
Blood sampling
Collection of a 30mL peripheral blood sample in heparin at several times: during surgical and medical treatment (before surgery, before the start of mAbs and after mAbs)

Locations

Country Name City State
France Gustave Roussy Villejuif Val De Marne

Sponsors (1)

Lead Sponsor Collaborator
Gustave Roussy, Cancer Campus, Grand Paris

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Immunophenotyping of immune infiltrates by flow cytometry Immunophenotyping analysis by flow cytometry (Cyan, Beckman Coulter): identification of several immune sub-populations (T-B-NK lymphocytes, myeloid and tumor cells); identifications of several receptors and ligands (PD1 / PDL1, Tim-3 / HAVCR2,, CTLA-4, 4-1BB / 4-1BBL, Fas / FasL, TRAIL, OX40 / OX40L, ICOS / ICOSL, CD69, CD25 / CD127, NKp46 / NKp30, NKG2D / NKG2DL, galectin-9, MHC class I and II, B7H3 / B7H6); identification of memory subpopulations (CD45RA / CD27 / CCR7) and, if available, intra-cytoplasmic labeling (CXCR3, CCR6, Granzyme B, KI67, TNFa IFNg, IL-17 and IL-21). Up yo one year
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