Deciphering Mechanisms Underlying Cancer Immunogenicity

NCT ID: NCT03958240

Last Updated: 2025-09-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-17
• Study Completion Date: 2033-01-31

Brief Summary

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Patient with local and/or metastatic solid malignant tumor

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

Group Type: OTHER

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

Intervention Type: OTHER

Blood samples, tumor biopsy specimens and ascites samples will be collected at different time points (if feasible, according to the samples taken in the standard practice) for a maximum follow-up period of 5 years from baseline:

• at Baseline.
• at every surgical procedure or tumor biopsy.
• every 6 months (± 2 months) (only blood sample).
• at the time of the progression or recurrence, additional samples will be collected, and optionally at the time of the following progressions or recurrences (if applicable).

For patients undergoing a RT treatment, blood samples will be collected before the RT (i.e. at the time of planning CT-scan), at the last session of RT (± 2 days) and 3 months after the end of the RT (± 2 weeks).

Interventions

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

Blood samples, tumor biopsy specimens and ascites samples will be collected at different time points (if feasible, according to the samples taken in the standard practice) for a maximum follow-up period of 5 years from baseline:

• at Baseline.
• at every surgical procedure or tumor biopsy.
• every 6 months (± 2 months) (only blood sample).
• at the time of the progression or recurrence, additional samples will be collected, and optionally at the time of the following progressions or recurrences (if applicable).

For patients undergoing a RT treatment, blood samples will be collected before the RT (i.e. at the time of planning CT-scan), at the last session of RT (± 2 days) and 3 months after the end of the RT (± 2 weeks).

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut Claudius Regaud

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hopital Larrey

Toulouse, , France

Site Status: RECRUITING

Hopital Rangueil

Toulouse, , France

Site Status: RECRUITING

Institut Universitaire du Cancer Toulouse - Oncopole

Toulouse, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Alejandra MARTINEZ

Role: CONTACT

martinez.alejandra@iuct-oncopole.fr

+33 5 31 15 53 66

Facility Contacts

Julien MAZIERES

Role: primary

mazieres.j@chu-toulouse.fr

05 67 77 18 37

Rosine GUIMBAUD

Role: primary

guimbaud.r@chu-toulouse.fr

05 61 32 21 42

Alejandra MARTINEZ

Role: primary

martinez.alejandra@iuct-oncopole.fr

+33 5 31 15 53 66

Other Identifiers

19 GENE 13

Identifier Type: -

Identifier Source: org_study_id