Deciphering Mechanisms Underlying Cancer Immunogenicity

Ovarian Cancer Clinical Trial

— DECIDE  

Official title:

Deciphering Mechanisms Underlying Cancer Immunogenicity

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03958240
• Other study ID #: 19 GENE 13
• Status: Recruiting
• Phase: N/A
• Start date: January 17, 2020
• Est. completion date: September 2029

Study information

• Verified date: July 2023
• Source: Institut Claudius Regaud
• Contact: Alejandra MARTINEZ
• Phone: +33 5 31 15 53 66
• Email: martinez.alejandra[@]iuct-oncopole.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 900
• Est. completion date: September 2029
• Est. primary completion date: September 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anal Cancer
• Anus Neoplasms
• Carcinoma, Non-Small-Cell Lung
• Cervical Cancer
• Cervical Intraepithelial Neoplasia 3
• Glioblastoma
• Glioblastoma Multiforme of Brain Stem
• Head and Neck Cancer
• Head and Neck Neoplasms
• Neoplasms
• Non Small Cell Lung Cancer
• Ovarian Cancer
• Ovarian Neoplasms
• Uterine Cervical Dysplasia
• Uterine Cervical Neoplasms

Intervention

Other:
• 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): 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, 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).

Locations

Country	Name	City	State
France	Hopital Larrey	Toulouse
France	Hopital Rangueil	Toulouse
France	Institut Universitaire du Cancer Toulouse - Oncopole	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Institut Claudius Regaud

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of CD4 and CD8 T cells expressing PD-1		5 years for each patient
Secondary	Rate of patients presenting a high Trm (Tissue resident memory) infiltrate in tumor samples		5 years for each patient