Deciphering Mechanisms Underlying Cancer Immunogenicity (DECIDE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03958240|
Recruitment Status : Not yet recruiting
First Posted : May 21, 2019
Last Update Posted : August 12, 2019
This trial is a translational, open-label, monocentric, 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 for their standard of care at the IUCT-O.
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.
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer Ovarian Cancer Cervical Cancer Cervical Intraepithelial Neoplasia 3 Glioblastoma Multiforme of Brain Stem Non Small Cell Lung Cancer Anal Cancer||Other: Blood samples, tumor biopsy specimens and ascites samples will be collected.||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||900 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Deciphering Mechanisms Underlying Cancer Immunogenicity|
|Estimated Study Start Date :||September 2019|
|Estimated Primary Completion Date :||September 2029|
|Estimated Study Completion Date :||September 2029|
Patient with local and/or metastatic solid malignant tumor
Patient receiving an anticancer treatment in the context of their standard care.
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):
If tumor biopsy and/or ascites sampling are performed during the standard care, a sample will be collected for the study at baseline and at the time of progression.
- Percentage of CD4 and CD8 T cells expressing PD-1 [ Time Frame: 5 years for each patient ]
- Rate of patients presenting a high Trm (Tissue resident memory) infiltrate in tumor samples [ Time Frame: 5 years for each patient ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03958240
|Contact: Alejandra MARTINEZ||+33 5 31 15 53 email@example.com|
|Institut Universitaire du Cancer Toulouse - Oncopole||Not yet recruiting|
|Contact: Alejandra MARTINEZ +33 5 31 15 53 66 firstname.lastname@example.org|