Metastatic Colorectal CancerEpitopes-CRC02NCT02817178
Study for Validation of Immunological Biomarkers in Patients With Metastatic Colorectal Cancer
A study testing Additional biological samples in people with Metastatic Colorectal Cancer, run by Centre Hospitalier Universitaire de Besancon at 9 sites in France.
Trial summary
The investigators recently identified promiscuous HLA-DR-derived epitopes from the human telomerase reverse transcriptase (TERT) called universal cancer peptides (UCP), to study tumor-specific CD4+ T cell responses. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- Additional biological samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 258 participants
- Where
- 9 sitesFrance
- Study dates
- Mar 2013to 6 Jul 2020
- 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
- Performance status ECOG-WHO 0, 1 or 2
- Metastatic colorectal cancer Histologically proved
- signed written informed consent
Who cannot join
- previous treatment (chemotherapy, targeted therapy, surgery) for metastatic disease
- history of autoimmune disease
- patients under immunotherapy systemic treatment or immunosuppressive drugs or stopped for less than 6 months to the enrollment in this study.
- corticoids ≥ 1mg/kg
- acute or chronic infectious disease during treatment or stopped for less than six months
- other malignancy within the last 5 years, except for adequately treated carcinoma in situ of the cervix or squamous carcinoma of the skin, or adequately controlled limited basal cell skin cancer.
Show all 9Show fewer
- pregnancy, breast-feeding or absence of adequate contraception for fertile patients
- patient with any medical or psychiatric condition or disease which would make the patient inappropriate for entry into this study.
- patient under guardianship, curator or under the protection of justice.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
France9 sites
Centre Hospitalier Régional Universitaire de Besançon
Besançon
Polyclinique de Franche-Comté
Besançon
Hôpitaux Civils de Colmar
Colmar
Centre Georges François Leclerc
Dijon
Hôpital Nord Franche-Comté
Montbéliard
Institut de Cancérologie de Lorraine
Nancy
Hôpital Européen Georges Pompidou
Paris
Centre Paul Strauss
Strasbourg
Centre Hospitalier Universitaire de Tours
Tours
About this study
Official title: Prospective Study for Validation of Immunological Biomarkers in Patients With Metastatic Colorectal Cancer
The investigators recently identified promiscuous HLA-DR-derived epitopes from the human telomerase reverse transcriptase (TERT) called universal cancer peptides (UCP), to study tumor-specific CD4+ T cell responses.
The investigators found high frequency of naturally occuring UCP-specific TH1 cells in long term survival of metastatic colorectal cancer (CRC) previously treated by 5 fluoro-uracil -oxaliplatin (Folfox) +/- bevacizumab regiment (Godet et al. OncoImmunology 2012 and unpublished data).
Epitopes-CRC02 is a French prospective multicenter study which will evaluate the post chemotherapy and post surgery modulation of host tumor-specific CD4 TH1 cell responses in metastatic colorectal cancer patients and their correlation with progression-free survival.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- Additional biological samples
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Additional biological samplesOther
blood and tumor tissue samples
| Study group | Role | What they receive |
|---|---|---|
| Additional biological samples | Other | Additional blood samples will be realized specifically to the study at baseline, at 1 month, at 3 months, and 1 month after surgery (if applicable).
Peripheral Blood Mononuclear Cell (PBMC) and plasma will be collected. Tissue tumor is collected during surgery if applicable. Receives: Other: Additional biological samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
time interval between the date of initiation of treatment and the date of first progression (local, remote [extent of the disease by RECIST v1.1] second cancer) or death from any cause.
Measured: date of first progression of the disease (within 3 years after the enrollment in the study)]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2016 (estimated)
- Study startMar 2013
- Primary completion11 Jun 2017
- Study completion6 Jul 2020
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 Colorectal 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
- 258 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stefano KIM, Dr, Principal investigator, CHU DE BESANCON
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02817178
- Sponsor's protocol ID
- Epitopes-CRC02
- Acronym
- Epitopes-CRC02
- Status last verified
- May 2022
- First submitted
- 27 Jun 2016
- Last updated
- 11 May 2022
- Results posted
- No
Publications
Kroemer M, Turco C, Spehner L, Viot J, Idirene I, Bouard A, Renaude E, Deschamps M, Godet Y, Adotevi O, Limat S, Heyd B, Jary M, Loyon R, Borg C. Investigation of the prognostic value of CD4 T cell subsets expanded from tumor-infiltrating lymphocytes of colorectal cancer liver metastases. J Immunother Cancer. 2020 Nov;8(2):e001478. doi: 10.1136/jitc-2020-001478.
PubMed 33229508
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study for Validation of Immunological Biomarkers in Patients With Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT02817178
- Acronym / sponsor ID
- Epitopes-CRC02 / Epitopes-CRC02
- Conditions
- Metastatic Colorectal Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 258 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- Mar 2013 (actual)
- Primary completion
- 11 Jun 2017 (actual)
- Study completion
- 6 Jul 2020 (actual)
- First posted
- 29 Jun 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 investigators recently identified promiscuous HLA-DR-derived epitopes from the human telomerase reverse transcriptase (TERT) called universal cancer peptides (UCP), to study tumor-specific CD4+ T cell responses.
The investigators found high frequency of naturally occuring UCP-specific TH1 cells in long term survival of metastatic colorectal cancer (CRC) previously treated by 5 fluoro-uracil -oxaliplatin (Folfox) +/- bevacizumab regiment (Godet et al. OncoImmunology 2012 and unpublished data).
Epitopes-CRC02 is a French prospective multicenter study which will evaluate the post chemotherapy and post surgery modulation of host tumor-specific CD4 TH1 cell responses in metastatic colorectal cancer patients and their correlation with progression-free survival.
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 specifically to the study at baseline, at 1 month, at 3 months, and 1 month after surgery (if applicable). Peripheral Blood Mononuclear Cell (PBMC) and plasma will be collected. Tissue tumor is collected during surgery if applicable. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Performance status ECOG-WHO 0, 1 or 2
- Metastatic colorectal cancer Histologically proved
- signed written informed consent
Key exclusion criteria (9 listed)
- previous treatment (chemotherapy, targeted therapy, surgery) for metastatic disease
- history of autoimmune disease
- patients under immunotherapy systemic treatment or immunosuppressive drugs or stopped for less than 6 months to the enrollment in this study.
- corticoids ≥ 1mg/kg
- acute or chronic infectious disease during treatment or stopped for less than six months
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 tumor tissue samples | Other | Additional biological samples |
Primary outcome
Progression-free survival
Time frame: date of first progression of the disease (within 3 years after the enrollment in the study)]
time interval between the date of initiation of treatment and the date of first progression (local, remote [extent of the disease by RECIST v1.1] second cancer) 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 11 May 2022.
- Derived from this study: PubMed 33229508Kroemer M, Turco C, Spehner L, Viot J, Idirene I, Bouard A, Renaude E, Deschamps M, Godet Y, Adotevi O, Limat S, Heyd B, Jary M, Loyon R, Borg C. Investigation of the prognostic value of CD4 T cell subsets expanded from tumor-infiltrating lymphocytes of colorectal cancer liver metastases. J Immunother Cancer. 2020 Nov;8(2):e001478. doi: 10.1136/jitc-2020-001478.
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CRC
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.
Stefano KIM, Dr principal investigator
CHU DE BESANCON
9 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 Colorectal Cancer, run by Centre Hospitalier Universitaire de Besancon at 9 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 3 inclusion and 9 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 11 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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?
Progression-free survival (time frame: date of first progression of the disease (within 3 years after the enrollment in the study)]). 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 NCT02817178, 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 11 May 2022.