Head and Neck CancerDECIDENCT03958240
Deciphering Mechanisms Underlying Cancer Immunogenicity
A study testing Blood samples, tumor biopsy specimens and ascites samples will be collected. in people with Head and Neck Cancer and Ovarian Cancer, run by Institut Claudius Regaud at 3 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Ovarian Cancer, Cervical Cancer
- What is being tested?
- Blood samples, tumor biopsy specimens and ascites samples will be collected.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,100 participants
- Where
- 3 sitesFrance
- Study dates
- 17 Jan 2020to Jan 2033
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites, 3 recruiting
- Recruiting
Hopital Larrey
Toulouse, 31059
Julien MAZIERES, 05 67 77 18 37, mazieres.j@chu-toulouse.fr
- Recruiting
Hopital Rangueil
Toulouse, 31059
Rosine GUIMBAUD, 05 61 32 21 42, guimbaud.r@chu-toulouse.fr
- Recruiting
Institut Universitaire du Cancer Toulouse - Oncopole
Toulouse
Alejandra MARTINEZ, +33 5 31 15 53 66, martinez.alejandra@iuct-oncopole.fr
About this study
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.
Read more
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.
- Conditions
- Head and Neck Cancer, Ovarian Cancer, Cervical Cancer, Cervical Intraepithelial Neoplasia 3, Glioblastoma Multiforme of Brain Stem, Non Small Cell Lung Cancer
- Being tested
- Blood samples, tumor biopsy specimens and ascites samples will be collected.
- Keywords
- Head and Neck Cancer, Ovarian Cancer, Cervical Cancer, Cervical Intraepithelial Neoplasia 3, Glioblastoma Multiforme of Brain Stem, Non Small Cell Lung Cancer, Anal Cancer
- Medical subject headings
- Head and Neck Neoplasms, Ovarian Neoplasms, Uterine Cervical Neoplasms, Carcinoma, Non-Small-Cell Lung, Anus Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
| Study group | Role | What they receive |
|---|---|---|
| Patient with local and/or metastatic solid malignant tumor | Other | Patient receiving an anticancer treatment in the context of their standard care. Receives: Other: Blood samples, tumor biopsy specimens and ascites samples will be collected. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of CD4 and CD8 T cells expressing PD-1
Measured: 5 years for each patient
Secondary outcomes (1)
Rate of patients presenting a high Trm (Tissue resident memory) infiltrate in tumor samples
Measured: 5 years for each patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2019
- Study start17 Jan 2020
- Primary completionJan 2033 (estimated)
- Study completionJan 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Claudius Regaud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03958240
- Sponsor's protocol ID
- 19 GENE 13
- Acronym
- DECIDE
- Status last verified
- Sep 2025
- First submitted
- 20 May 2019
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deciphering Mechanisms Underlying Cancer Immunogenicity
- ClinicalTrials.gov ID
- NCT03958240
- Acronym / sponsor ID
- DECIDE / 19 GENE 13
- Conditions
- Head and Neck Cancer, Ovarian Cancer, Cervical Cancer, Cervical Intraepithelial Neoplasia 3, Glioblastoma Multiforme of Brain Stem, Non Small Cell Lung Cancer
- Keywords
- Head and Neck Cancer, Ovarian Cancer, Cervical Cancer, Cervical Intraepithelial Neoplasia 3, Glioblastoma Multiforme of Brain Stem, Non Small Cell Lung Cancer, Anal Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,100 participants (estimated)
- Lead sponsor
- Institut Claudius RegaudUniversity, hospital or other
- Study start
- 17 Jan 2020 (actual)
- Primary completion
- Jan 2033 (estimated)
- Study completion
- Jan 2033 (estimated)
- First posted
- 21 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with local and/or metastatic solid malignant tumor | Other | Other: Blood samples, tumor biopsy specimens and ascites samples will be collected.Patient receiving an anticancer treatment in the context of their standard care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) 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). | Other | Patient with local and/or metastatic solid malignant tumor |
Primary outcome
Percentage of CD4 and CD8 T cells expressing PD-1
Time frame: 5 years for each patient
1 secondary outcome
Rate of patients presenting a high Trm (Tissue resident memory) infiltrate in tumor samples
Time frame: 5 years for each patient
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood samples, tumor biopsy specimens and ascites samples will be collected. in people with Head and Neck Cancer and Ovarian Cancer, run by Institut Claudius Regaud at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alejandra MARTINEZ (+33 5 31 15 53 66, martinez.alejandra@iuct-oncopole.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of CD4 and CD8 T cells expressing PD-1 (time frame: 5 years for each patient). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.