Metastatic CancerEpitopes-CRC01NCT02838381
Study of Genetic and Cellular Immunological Parameters Predictive of Disease-free Survival in Patients With Metastatic Cancer
A study testing Additional biological samples in people with Metastatic Cancer, run by Centre Hospitalier Universitaire de Besancon at 2 sites in France.
Trial summary
The aim of this study is to characterize the genetic and cellular immunological parameters of metastatic digestive cancer patients having short and long responses to chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Cancer
- What is being tested?
- Additional biological samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 553 participants
- Where
- 2 sitesFrance
- Study dates
- Jun 2012to 11 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- For all patients:
- signed written informed consent
- For cohort A:
- patient with metastatic colorectal cancer with first-line therapy by chemotherapy +/- surgery and with a disease-free survival > or = at 20 months
- Ct-scan realized in the previous 4 weeks and showing no progression according to the Recist criteria v1.1
- For cohort B:
Show all 11Show fewer
- patient treated for metastatic colorectal cancer and chemotherapy responder (obtention of an objective response according to the Recist criteria V1.1 in first-line therapy), with a disease-free survival < 10 months (disease progression must be confirmed by CT scan evaluation according to Recist v1.1 criteria)
- For cohort C:
- patients with no metastatic rectum cancer in complete remission after chemotherapy and/or radiotherapy
- For cohort D:
- patients with metastatic or locally advanced cancer in complete remission after treatment, non eligible in the other cohorts
Who cannot join
- For all patients:
- patient with any medical or psychiatric condition or disease which would make the patient inappropriate for entry into this study
- patient with a neurodegenerative disease
- patient under guardianship, curator or under the protection of justice
Trial locations and contacts
2 sites in 1 country.
France2 sites
Centre Hospitalier Universitaire de Besançon
Besançon
Hôpital Nord Franche Comté
Montbéliard
About this study
The aim of this study is to characterize the genetic and cellular immunological parameters of metastatic digestive cancer patients having short and long responses to chemotherapy.
- Conditions
- Metastatic Cancer
- Being tested
- Additional biological samples
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Additional biological samplesOther
blood and tissue samples
| Study group | Role | What they receive |
|---|---|---|
| Additional biological samples | Other | Additional blood samples will be realized at the inclusion of patients. Two optional blood samples could be realized if necessary with at least 3 months apart.
Peripheral Blood Mononuclear Cells (PBMC) will be collected. Tissue tumor will be collected if available. Receives: Other: Additional biological samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
frequency of peripheral T cell immune responses in the presence of antigenic peptides associated with digestive cancer
Measured: at inclusion
progression-free survival
time interval between the date of inclusion and the date of first progression or death from any cause.
Measured: within 5 years after the inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2016 (estimated)
- Study startJun 2012
- Primary completion31 Dec 2023
- Study completion11 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic CancerStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- 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
- 553 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02838381
- Sponsor's protocol ID
- P/2011/117
- Acronym
- Epitopes-CRC01
- Status last verified
- Dec 2024
- First submitted
- 18 Jul 2016
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
Lopez M, Spehner L, Andre F, Viot J, Seffar E, Marguier A, Curtit E, Meynard G, Dobi E, Ladoire S, Boidot R, Loyon R, Derangere V, Bidard FC, Borg C, Mansi L, Kroemer M. Exploring the role of ESR1 mutations in metastatic hormone receptor-positive breast cancer T cell immune surveillance disruption. Breast Cancer Res. 2025 Feb 7;27(1):19. doi: 10.1186/s13058-025-01962-6.
PubMed 39920833
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Genetic and Cellular Immunological Parameters Predictive of Disease-free Survival in Patients With Metastatic Cancer
- ClinicalTrials.gov ID
- NCT02838381
- Acronym / sponsor ID
- Epitopes-CRC01 / P/2011/117
- Conditions
- Metastatic Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 553 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 11 Jun 2024 (actual)
- First posted
- 20 Jul 2016 (estimated)
- 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.
The aim of this study is to characterize the genetic and cellular immunological parameters of metastatic digestive cancer patients having short and long responses to chemotherapy.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Additional biological samples | Other | Other: Additional biological samplesAdditional blood samples will be realized at the inclusion of patients. Two optional blood samples could be realized if necessary with at least 3 months apart. Peripheral Blood Mononuclear Cells (PBMC) will be collected. Tissue tumor will be collected if available. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- signed written informed consent
- patient with metastatic colorectal cancer with first-line therapy by chemotherapy +/- surgery and with a disease-free survival > or = at 20 months
- Ct-scan realized in the previous 4 weeks and showing no progression according to the Recist criteria v1.1
- patient treated for metastatic colorectal cancer and chemotherapy responder (obtention of an objective response according to the Recist criteria V1.1 in first-line therapy), with a disease-free survival < 10 months (disease progression must be confirmed by CT scan evaluation according to Recist v1.1 criteria)
- patients with no metastatic rectum cancer in complete remission after chemotherapy and/or radiotherapy
Key exclusion criteria (4 listed)
- patient with any medical or psychiatric condition or disease which would make the patient inappropriate for entry into this study
- patient with a neurodegenerative disease
- patient under guardianship, curator or under the protection of justice
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 |
|---|---|---|
| Additional biological samplesblood and tissue samples | Other | Additional biological samples |
Primary outcome
frequency of peripheral T cell immune responses in the presence of antigenic peptides associated with digestive cancer
Time frame: at inclusion
progression-free survival
Time frame: within 5 years after the inclusion
time interval between the date of inclusion and the date of first progression or death from any cause.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Derived from this study: PubMed 39920833Lopez M, Spehner L, Andre F, Viot J, Seffar E, Marguier A, Curtit E, Meynard G, Dobi E, Ladoire S, Boidot R, Loyon R, Derangere V, Bidard FC, Borg C, Mansi L, Kroemer M. Exploring the role of ESR1 mutations in metastatic hormone receptor-positive breast cancer T cell immune surveillance disruption. Breast Cancer Res. 2025 Feb 7;27(1):19. doi: 10.1186/s13058-025-01962-6.
Related trials for Metastatic Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingObservational study
A Non-Interventional Study PASS to Characterize Secondary Malignancies of Tcell Origin Following Tisagenlecleucel Therapy
Secondary Malignancies of T-cell Origin
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Additional biological samples in people with Metastatic Cancer, run by Centre Hospitalier Universitaire de Besancon at 2 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 11 inclusion and 4 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: finished, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
frequency of peripheral T cell immune responses in the presence of antigenic peptides associated with digestive cancer (time frame: at inclusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02838381, which also lists 1 linked publication.
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 27 Dec 2024.