Deciphering Mechanisms Underlying Cancer Immunogenicity

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitut Claudius Regaud

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Age ≥ 18 years at the time of study entry

Patient followed within a standard of care procedure or clinical trial

ECOG Performance status 0-2

Disqualifiers

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

Any condition contraindicated with blood sampling procedures required by the protocol (including Hemoglobin < 8g/dl)

Patient pregnant, or breast-feeding

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

Trial design

Design model

Single group

Treatments tested in this trial

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

    Other intervention

    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).

Treatment groups

1,100 Participants
are divided into 1 treatment group
Group A: Patient with local and/or metastatic solid malignant tumorOther 1 intervention

Trial outcomes

Primary outcomes

1

Percentage of CD4 and CD8 T cells expressing PD-1

Time frame
5 years for each patient

Secondary outcomes

1

Rate of patients presenting a high Trm (Tissue resident memory) infiltrate in tumor samples

Time frame
5 years for each patient

Other outcomes

Sponsors and contacts

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