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出境医 / 临床实验 / Deciphering Mechanisms Underlying Cancer Immunogenicity (DECIDE)
Deciphering Mechanisms Underlying Cancer Immunogenicity (DECIDE)
Study Description
Brief Summary:
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 Design
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 900 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Other |
| Official Title: | Deciphering Mechanisms Underlying Cancer Immunogenicity |
| Actual Study Start Date : | January 17, 2020 |
| Estimated Primary Completion Date : | September 2029 |
| Estimated Study Completion Date : | September 2029 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
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. |
Outcome Measures
Primary Outcome Measures :
- Percentage of CD4 and CD8 T cells expressing PD-1 [ Time Frame: 5 years for each patient ]
Secondary Outcome Measures :
- Rate of patients presenting a high Trm (Tissue resident memory) infiltrate in tumor samples [ Time Frame: 5 years for each patient ]
Eligibility Criteria
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patient with histologically documented local and/or metastatic solid malignant tumor (head and neck, ovarian, cervical, pre-invasive CIN III cervical lesions, and other pathology types including, but not limited to glioblastoma, NSCLC and anal cancer)
- Age ≥ 18 years at the time of study entry
- Patient for whom an anticancer treatment plan (whatever it is, but including preferentially a surgical procedure) has been decided during a multidisciplinary meeting, in the context of their standard of care at the IUCT-O.
- ECOG performance status 0-2
- Signed written informed consent
- Patient able to participate and willing to give informed consent prior performance of any study-related procedures and to comply with the study protocol
- Patient affiliated to a Social Health Insurance in France
- Patient may participate to other clinical trials
Exclusion Criteria:
- 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
- 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.
- Patient who has forfeited his/her freedom by administrative or legal award or who is under guardianship.
Contacts and Locations
Contacts
| Contact: Alejandra MARTINEZ | +33 5 31 15 53 66 | martinez.alejandra@iuct-oncopole.fr |
Locations
| France | |
| Hopital Larrey | Recruiting |
| Toulouse, France, 31059 | |
| Contact: Julien MAZIERES 05 67 77 18 37 mazieres.j@chu-toulouse.fr | |
| Institut Universitaire du Cancer Toulouse - Oncopole | Recruiting |
| Toulouse, France | |
| Contact: Alejandra MARTINEZ +33 5 31 15 53 66 martinez.alejandra@iuct-oncopole.fr | |
Sponsors and Collaborators
Institut Claudius Regaud
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | May 20, 2019 | ||||
| First Posted Date ICMJE | May 21, 2019 | ||||
| Last Update Posted Date | November 6, 2020 | ||||
| Actual Study Start Date ICMJE | January 17, 2020 | ||||
| Estimated Primary Completion Date | September 2029 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Percentage of CD4 and CD8 T cells expressing PD-1 [ Time Frame: 5 years for each patient ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
Rate of patients presenting a high Trm (Tissue resident memory) infiltrate in tumor samples [ Time Frame: 5 years for each patient ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Deciphering Mechanisms Underlying Cancer Immunogenicity | ||||
| Official Title ICMJE | Deciphering Mechanisms Underlying Cancer Immunogenicity | ||||
| Brief Summary |
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:
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. |
||||
| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Other |
||||
| Condition ICMJE |
|
||||
| Intervention ICMJE | 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. |
||||
| Study Arms ICMJE | Patient with local and/or metastatic solid malignant tumor
Patient receiving an anticancer treatment in the context of their standard care.
Intervention: Other: Blood samples, tumor biopsy specimens and ascites samples will be collected.
|
||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE |
900 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Estimated Study Completion Date ICMJE | September 2029 | ||||
| Estimated Primary Completion Date | September 2029 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
||||
| Sex/Gender ICMJE |
|
||||
| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE |
|
||||
| Listed Location Countries ICMJE | France | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03958240 | ||||
| Other Study ID Numbers ICMJE | 19 GENE 13 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| U.S. FDA-regulated Product |
|
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| IPD Sharing Statement ICMJE | Not Provided | ||||
| Responsible Party | Institut Claudius Regaud | ||||
| Study Sponsor ICMJE | Institut Claudius Regaud | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| PRS Account | Institut Claudius Regaud | ||||
| Verification Date | November 2020 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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