NCT03958240 Deciphering Mechanisms Underlying Cancer Immunogenicity
| NCT ID | NCT03958240 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Institut Claudius Regaud |
| Condition | Head and Neck Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,100 participants |
| Start Date | 2020-01-17 |
| Primary Completion | 2033-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,100 participants in total. It began in 2020-01-17 with a primary completion date of 2033-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT03958240 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Head and Neck Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03958240 currently recruiting?
Yes, NCT03958240 is actively recruiting participants. Contact the research team at martinez.alejandra@iuct-oncopole.fr for enrollment information.
Where is the NCT03958240 trial being conducted?
This trial is being conducted at Toulouse, France, Toulouse, France, Toulouse, France.
Who is sponsoring the NCT03958240 clinical trial?
NCT03958240 is sponsored by Institut Claudius Regaud. The trial plans to enroll 1,100 participants.
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