Deciphering Mechanisms Underlying Cancer Immunogenicity

Last updated: July 22, 2024
Sponsor: Institut Claudius Regaud
Overall Status: Active - Recruiting

Phase

N/A

Condition

Ovarian Cancer

Cervical Cancer

Ovarian Cysts

Treatment

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

Clinical Study ID

NCT03958240
19 GENE 13
  • Ages > 18
  • All Genders

Study Summary

This trial is a translational, open-label, multicentric, prospective cohort study of 900 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.

Eligibility Criteria

Inclusion

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 limitedto glioblastoma, NSCLC and anal cancer) or patients with pre-invasive cervical highgrade 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 performanceof 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

Exclusion Criteria:

  1. Known history of positive test for Hepatitis B virus or Hepatitis C virus orImmunodeficiency Virus (HIV) or Hanta virus

  2. Any condition contraindicated with blood sampling procedures required by theprotocol (including Hemoglobin < 8g/dl)

  3. Patient pregnant, or breast-feeding

  4. Any psychological, familial, geographic or social situation, according to thejudgment of investigator, potentially preventing the provision of informed consentor compliance to study procedure

  5. Patient who has forfeited his/her freedom by administrative or legal award or who isunder guardianship

Study Design

Total Participants: 900
Treatment Group(s): 1
Primary Treatment: Blood samples, tumor biopsy specimens and ascites samples will be collected.
Phase:
Study Start date:
January 17, 2020
Estimated Completion Date:
September 30, 2029

Connect with a study center

  • Hopital Larrey

    Toulouse, 31059
    France

    Active - Recruiting

  • Hopital Rangueil

    Toulouse, 31059
    France

    Active - Recruiting

  • Institut Universitaire du Cancer Toulouse - Oncopole

    Toulouse,
    France

    Active - Recruiting

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