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NCT Number: NCT03958240

Deciphering Mechanisms Underlying Cancer Immunogenicity

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.

Recruiting

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Key information

Conditions

Head and Neck Cancer Adnexal Diseases Anal Cancer Anus Diseases Anus Neoplasms Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Cervical Cancer Cervical Intraepithelial Neoplasia 3 Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Glioblastoma Multiforme of Brain Stem Gonadal Disorders Head and Neck Neoplasms Intestinal Diseases Intestinal Neoplasms Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Non Small Cell Lung Cancer Ovarian Cancer Ovarian Diseases Ovarian Neoplasms Rectal Diseases Rectal Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hopital Larrey, Toulouse, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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)
Age ≥ 18 years at the time of study entry
Patient followed within a standard of care procedure or clinical trial
ECOG Performance status 0-2
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 (including Hemoglobin < 8g/dl)
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

Treatment and study plan

Blood samples, tumor biopsy specimens and ascites samples will be collected.

Other

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) for a maximum follow-up period of 5 years from baseline:

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, additional samples will be collected, and optionally at the time of the following progressions or recurrences (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).

Primary outcomes

Percentage of CD4 and CD8 T cells expressing PD-1

Time frame: 5 years for each patient

Secondary outcomes

Rate of patients presenting a high Trm (Tissue resident memory) infiltrate in tumor samples

Time frame: 5 years for each patient

Study contacts

Contact information is provided by the study sponsor or research team.

Alejandra MARTINEZ

CONTACT

[email protected]

+33 5 31 15 53 66

Sponsors and collaborators

Lead sponsor

Institut Claudius Regaud

Other

Registry information

Acronym: DECIDE

Important dates

Study start: 2020
Primary completion: 2033
Study completion: 2033
First posted: May 21, 2019
Registry last updated: Sep 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Recruiting