ClinicalTrials.gg
RecruitingNCT03958240DECIDEUpdated Sep 15, 2025

Deciphering Mechanisms Underlying Cancer Immunogenicity

An interventional study of Blood samples, tumor biopsy specimens and ascites samples will be collected. in Head and Neck Cancer, Ovarian Cancer and Cervical Cancer, sponsored by Institut Claudius Regaud. Recruiting at 3 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-15.

Sponsored by Institut Claudius Regaud · Not applicable, Interventional, and Other

From the registry’s dates

  • Started Jan 2020; still recruiting 6 years 9 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
1,100
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Head and Neck Cancer
  • Ovarian Cancer
  • Cervical Cancer
  • Cervical Intraepithelial Neoplasia 3
  • Glioblastoma Multiforme of Brain Stem
  • Non Small Cell Lung Cancer
  • Anal 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
03

In context

Head and Neck Neoplasms

2,710 studies on the registry are indexed under Head and Neck Neoplasms; 594 are open to participants now.

This study's planned enrollment of 1,100 is above the median of 46 across 2,032 interventional studies indexed under Head and Neck Neoplasms.

Browse Head and Neck Neoplasms studies →

Lead sponsor

Institut Claudius Regaud is the lead sponsor of 117 studies on the registry; 33 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Patient with documented local or 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)
  2. Age ≥ 18 years at the time of study entry
  3. Patient followed within a standard of care procedure or clinical trial
  4. Performance status 0-2
  5. Patient able to participate and willing to give prior performance of any study-related procedures and to comply with the study protocol
  6. Patient affiliated to a Social Health Insurance in France
  7. Patient may participate to other clinical trials

Exclusion criteria

Exclusion Criteria:

  1. Known history of positive test for virus or virus or Immunodeficiency Virus () or Hanta virus
  2. Any condition with blood sampling procedures required by the protocol (including \< 8g/dl)
  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 or compliance to study procedure
  5. Patient who has forfeited his/her freedom by administrative or legal award or who is under guardianship
Terms in these criteria, in plain language(9)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
1,100 participants (estimated)

Study arms

  • Other
    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.

Interventions

  • OtherBlood 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).

06

What researchers measure

Primary outcomes

  1. Percentage of CD4 and CD8 T cells expressing PD-1

    Time frame: 5 years for each patient

Secondary outcomes

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

    Time frame: 5 years for each patient

07

Study locations

3 of 3 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 15, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03958240
Responsible party
Sponsor
First posted
May 21, 2019
Start date
Jan 17, 2020
Primary completion
Jan 2033 (estimated)
Completion
Jan 2033 (estimated)
Last update
Sep 15, 2025

Study contacts

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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion