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Deciphering Mechanisms Underlying Cancer Immunogenicity (DECIDE)

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ClinicalTrials.gov Identifier: NCT03958240
Recruitment Status : Not yet recruiting
First Posted : May 21, 2019
Last Update Posted : August 12, 2019
Sponsor:
Information provided by (Responsible Party):
Institut Claudius Regaud

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 900 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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


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):

  • at Baseline,
  • every 6 months (± 1 month) during the planned visits in the center for clinical standard care and for a maximum follow-up period of 5 years from baseline.

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.





Primary Outcome Measures :
  1. Percentage of CD4 and CD8 T cells expressing PD-1 [ Time Frame: 5 years for each patient ]

Secondary Outcome Measures :
  1. Rate of patients presenting a high Trm (Tissue resident memory) infiltrate in tumor samples [ Time Frame: 5 years for each patient ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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)
  2. Age ≥ 18 years at the time of study entry
  3. 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.
  4. ECOG performance status 0-2
  5. Signed written informed consent
  6. Patient able to participate and willing to give informed consent prior performance of any study-related procedures and to comply with the study protocol
  7. Patient affiliated to a Social Health Insurance in France
  8. 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
  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.

Information from the National Library of Medicine

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


Contacts
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Contact: Alejandra MARTINEZ +33 5 31 15 53 66 martinez.alejandra@iuct-oncopole.fr

Locations
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France
Institut Universitaire du Cancer Toulouse - Oncopole Not yet recruiting
Toulouse, France
Contact: Alejandra MARTINEZ    +33 5 31 15 53 66    martinez.alejandra@iuct-oncopole.fr   
Sponsors and Collaborators
Institut Claudius Regaud

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Responsible Party: Institut Claudius Regaud
ClinicalTrials.gov Identifier: NCT03958240     History of Changes
Other Study ID Numbers: 19 GENE 13
First Posted: May 21, 2019    Key Record Dates
Last Update Posted: August 12, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Institut Claudius Regaud:
Head and Neck Cancer
Ovarian Cancer
Cervical Cancer
Cervical Intraepithelial Neoplasia 3
Glioblastoma Multiforme of Brain Stem
Non Small Cell Lung Cancer
Anal Cancer

Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Glioblastoma
Head and Neck Neoplasms
Uterine Cervical Neoplasms
Neoplasms
Carcinoma in Situ
Cervical Intraepithelial Neoplasia
Anus Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Astrocytoma