Deciphering Mechanisms Underlying Cancer Immunogenicity (DECIDE)

Institut Claudius Regaud

Status: Enrolling

Conditions: Anal Cancer; Cervical Intraepithelial Neoplasia 3; Glioblastoma Multiforme of Brain Stem; Non Small Cell Lung Cancer; Ovarian Cancer; Head and Neck Cancer; Cervical Cancer

Treatments: Other: Blood samples, tumor biopsy specimens and ascites samples will be collected.

Study type: Interventional

Funder types: Other

Identifiers

NCT03958240

19 GENE 13

Details and patient eligibility

About

This trial is a translational, open-label, multicentric, prospective cohort study of 1100 patients aiming to describe the PD-1 (programmed death) expression in T cells (T lymphocytes) in different solid tumors.

The study will be conducted on a population of patients with local and/or metastatic malignant solid tumor and who are followed within a standard of care procedure or clinical trial.

Patients with any of the following tumor types may be enrolled in the trial:

• Head and neck cancer,
• Ovarian cancer,
• Cervical cancer,
• Pre-invasive CIN III cervical cancer (Cervical Intra-epithelial Neoplasia III cervical cancer),
• Other solid tumor types (including glioblastoma, NSCLC (Non-small cell lung cancer), anal cancer)

Each tumor type will be considered as an independent cohort.

For each included patient, biological specimen (tumor sample, blood samples and ascites samples if applicable) will be collected.

Study participation of each patient will be 5 years.

Enrollment: 1,100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patient with histologically documented local or metastatic solid malignant tumor (head and neck, ovarian, cervical, and other tumor types including, but not limited to glioblastoma, NSCLC and anal cancer) or patients with pre-invasive cervical high grade dysplasia (CIN II or III)
2. Age ≥ 18 years at the time of study entry
3. Patient followed within a standard of care procedure or clinical trial
4. ECOG Performance status 0-2
5. Patient able to participate and willing to give informed consent prior performance of any study-related procedures and to comply with the study protocol
6. Patient affiliated to a Social Health Insurance in France
7. Patient may participate to other clinical trials

Exclusion criteria

1. Known history of positive test for Hepatitis B virus or Hepatitis C virus or Immunodeficiency Virus (HIV) or Hanta virus
2. Any condition contraindicated with blood sampling procedures required by the protocol (including Hemoglobin < 8g/dl)
3. Patient pregnant, or breast-feeding
4. Any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure
5. Patient who has forfeited his/her freedom by administrative or legal award or who is under guardianship

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,100 participants in 1 patient group

Patient with local and/or metastatic solid malignant tumor

Other group

Description:

Patient receiving an anticancer treatment in the context of their standard care.

Treatment:

Other: Blood samples, tumor biopsy specimens and ascites samples will be collected.