Primary TumorCRC-ORGA2NCT05038358
Tumor Immune Microenvironment Involvement in Colorectal Cancer Chemoresistance Mechanisms
An observational study of Primary Tumor and Colon Tumor, run by University Hospital, Grenoble at 1 site in France.
Trial summary
Colorectal cancer is the third most common cancer worldwide and its progression-free survival is still low, around 10 months. Thirthy to 50% of patients do not respond to chemotherapy upon initiation of treatment, suggesting that early development of chemoresistance mechanisms remains a major challenge. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Tumor, Colon Tumor
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 12 Dec 2022to 31 Dec 2030
- Phase
- Observational
- 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
Study population: colorectal adenocarcinoma, naive from neo-adjuvant chemotherapy, indication of surgical resection
Who may be able to join
- Male and female over 18 years old.
- Managed at the CHUGA for a colorectal adenocarcinoma
- With an indication for immediate surgical resection as part of the care.
- Patient naive from neo-adjuvant chemotherapy
- Patient did not object to the CRC-ORGA-2 study
Who cannot join
- Patients protected by law (pregnant or breastfeeding women, minors, patients under guardianship or trusteeship, persons deprived of their liberty or hospitalized under duress).
- Patients with positive HIV, HBV, HCV serology.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
ARNAUD MILLET, MD, PHD contact
France1 site, 1 recruiting
- Recruiting
University Hospital of Grenoble Alpes
Grenoble, 38043
GAEL ROTH, MD, PHD, GRoth@chu-grenoble.fr
ARNAUD MILLET, MD,PHD, arnaud.millet@inserm.fr
About this study
Official title: Tumor Immune Microenvironment Involvement in Colorectal Cancer Chemoresistance Mechanisms: a Patient-derived Tumoroids Prospective Collection From Systemic Treatment Naive Tumors
Colorectal cancer is the third most common cancer worldwide and its progression-free survival is still low, around 10 months. Thirthy to 50% of patients do not respond to chemotherapy upon initiation of treatment, suggesting that early development of chemoresistance mechanisms remains a major challenge. In order to better characterize these mechanisms, the aim is to develop a model of tumoroids derived from patients with a colorectal tumors prior to any systemic anti cancer treatment. This project will both allow us to study the role of the immunological microenvironment in chemoresistance and identify new predictive markers of tumor response. It will then serve to develop innovative personalized medicine strategies by targeting the newly identified mechanisms. This study should in fine help to improve the cancer patient's care.
- Conditions
- Primary Tumor, Colon Tumor
- Keywords
- Organoid collection from fresh human primary colonic tumor tissue
- Medical subject headings
- Colonic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of viable organoids for 60 days of culture maintenance.
Measured: 60 days of culture maintenance.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2021
- Study start12 Dec 2022
- Primary completion30 Sep 2028 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary TumorStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- GAEL ROTH, MD, PHD, Principal investigator, university hospital of Grenoble alpes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05038358
- Sponsor's protocol ID
- 2021-A00793-38
- Acronym
- CRC-ORGA2
- Status last verified
- May 2026
- First submitted
- 31 Aug 2021
- Last updated
- 19 May 2026
- 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 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tumor Immune Microenvironment Involvement in Colorectal Cancer Chemoresistance Mechanisms: a Patient-derived Tumoroids Prospective Collection From Systemic Treatment Naive Tumors
- ClinicalTrials.gov ID
- NCT05038358
- Acronym / sponsor ID
- CRC-ORGA2 / 2021-A00793-38
- Conditions
- Primary Tumor, Colon Tumor
- Keywords
- Organoid collection from fresh human primary colonic tumor tissue
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 12 Dec 2022 (actual)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 9 Sep 2021 (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.
Colorectal cancer is the third most common cancer worldwide and its progression-free survival is still low, around 10 months. Thirthy to 50% of patients do not respond to chemotherapy upon initiation of treatment, suggesting that early development of chemoresistance mechanisms remains a major challenge. In order to better characterize these mechanisms, the aim is to develop a model of tumoroids derived from patients with a colorectal tumors prior to any systemic anti cancer treatment. This project will both allow us to study the role of the immunological microenvironment in chemoresistance and identify new predictive markers of tumor response. It will then serve to develop innovative personalized medicine strategies by targeting the newly identified mechanisms. This study should in fine help to improve the cancer patient's care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- colorectal adenocarcinoma, naive from neo-adjuvant chemotherapy, indication of surgical resection
Key inclusion criteria (5 listed)
- Male and female over 18 years old.
- Managed at the CHUGA for a colorectal adenocarcinoma
- With an indication for immediate surgical resection as part of the care.
- Patient naive from neo-adjuvant chemotherapy
- Patient did not object to the CRC-ORGA-2 study
Key exclusion criteria (2 listed)
- Patients protected by law (pregnant or breastfeeding women, minors, patients under guardianship or trusteeship, persons deprived of their liberty or hospitalized under duress).
- Patients with positive HIV, HBV, HCV serology.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of viable organoids for 60 days of culture maintenance.
Time frame: 60 days of culture maintenance.
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 19 May 2026.
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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.
ARNAUD MILLET, MD, PHD contact
GAEL ROTH, MD, PHD principal investigator
university hospital of Grenoble alpes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Tumor and Colon Tumor, run by University Hospital, Grenoble at 1 site 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 5 inclusion and 2 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 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 GAEL ROTH, MD, PHD (04 76 76 51 68 ext. 0033, GRoth@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of viable organoids for 60 days of culture maintenance. (time frame: 60 days of culture maintenance.). 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 19 May 2026.