Cancer of ColonFLUORIBNCT04274790
Impact of 5-Fluorouracil (5-FU) on Cancer Cells From Liver Metastases of Colon Cancer
An observational study of Cancer of Colon and Metastasis to Liver, run by Centre Leon Berard at 1 site in France.
Trial summary
Analyze the dynamics of incorporation of 5-fluorouracil into cancer cell ribosomes from liver metastases of patient with metastatic colon cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer of Colon, Metastasis to Liver
- What is being tested?
- Scheduled and planned surgery
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2021to 1 Mar 2023
- Phase
- Observational
- 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
Study population: Adult patients with metastatic colon cancer in the hepatic phase.
Who may be able to join
- Patient with metastatic colon cancer operated on and followed up at the Centre Leon Berard for liver metastasis.
- Patient affiliated to social security
Who cannot join
- Other pathologies that may interfere with biological evaluation, in particular known hepatic cirrhosis, whatever its origin, other liver overload diseases (hemochromatosis, Wilson's disease), but excluding steatosis (which can be chemo-induced).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analysis of the Impact of 5-Fluorouracil on the Translational Control and Plasticity of Cancer Cells From Liver Metastases of Colon Cancer
Analyze the dynamics of incorporation of 5-fluorouracil into cancer cell ribosomes from liver metastases of patient with metastatic colon cancer.
Read the detailed description
This is a monocentric, prospective, non-interventional cohort study in adult patients with metastatic colon cancer with hepatics metastasis.
Tumour samples collected for this study include:
- A fragment of the previously operated primary tumor: FFIP block and/or archived frozen tumor if available.
- A fragment of the liver metastasis(s) performed as part of standard metastasis surgery, this fragment will include a tumor area and a healthy area within the margin of excision. These samples collected in a fresh state will be analyzed immediately.
- Conditions
- Cancer of Colon, Metastasis to Liver
- Being tested
- Scheduled and planned surgery
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scheduled and planned surgeryProcedure or surgery
Collection of tumour samples from samples collected as part of standard patient management. Diagnostic pathological analysis will be a priority. These samples will be taken by experienced staff during the hospital visit scheduled as part of standard care.
| Study group | Role | What they receive |
|---|---|---|
| Metastatic colon cancer | Patient with metastatic colon cancer operated on and followed up at the Centre Leon Berard for liver metastasis. Receives: Procedure: Scheduled and planned surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
5-FU in ribosome
Rate of incorporation of 5-fluorouracil into ribosomes of tumor tissues and adjacent healthy tissues before surgery and after surgery.
Measured: Up to 24 months
Secondary outcomes (3)
Methylation profile of ribosomal RNAs
Analyze on a large scale the alterations of the 2'-O-methylation profile of ribosomal RNAs before surgery and after surgery
Measured: Up to 24 months
Transcriptomic and proteomic profile
Define a transcriptomic and proteomic profile of the collected samples before surgery and after surgery.
Measured: Up to 24 months
Specific molecular signature
Combination of the number of 5-fluorouracil molecules incorporated per rRNA molecule, the methylation profile and the transcriptomic profile before surgery and after surgery.
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2020
- Study start1 Jun 2021 (estimated)
- Primary completion1 Mar 2023 (estimated)
- Study completion1 Mar 2023 (estimated)
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer of ColonStudies of the same condition, open and under way.
- More trials run by Centre Leon BerardThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Leon Berard
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe CASSIER, MD, Principal investigator, Centre Leon Berard
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04274790
- Sponsor's protocol ID
- ET 19-127 FLUORIB
- Acronym
- FLUORIB
- Status last verified
- Feb 2024
- First submitted
- 10 Feb 2020
- Last updated
- 14 Feb 2024
- 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 14 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Impact of 5-Fluorouracil on the Translational Control and Plasticity of Cancer Cells From Liver Metastases of Colon Cancer
- ClinicalTrials.gov ID
- NCT04274790
- Acronym / sponsor ID
- FLUORIB / ET 19-127 FLUORIB
- Conditions
- Cancer of Colon, Metastasis to Liver
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centre Leon BerardUniversity, hospital or other
- Study start
- 1 Jun 2021 (estimated)
- Primary completion
- 1 Mar 2023 (estimated)
- Study completion
- 1 Mar 2023 (estimated)
- First posted
- 18 Feb 2020 (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.
Analyze the dynamics of incorporation of 5-fluorouracil into cancer cell ribosomes from liver metastases of patient with metastatic colon cancer.
Detailed description
This is a monocentric, prospective, non-interventional cohort study in adult patients with metastatic colon cancer with hepatics metastasis.
Tumour samples collected for this study include:
- A fragment of the previously operated primary tumor: FFIP block and/or archived frozen tumor if available.
- A fragment of the liver metastasis(s) performed as part of standard metastasis surgery, this fragment will include a tumor area and a healthy area within the margin of excision. These samples collected in a fresh state will be analyzed immediately.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Metastatic colon cancer | – | Procedure: Scheduled and planned surgeryPatient with metastatic colon cancer operated on and followed up at the Centre Leon Berard for liver metastasis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with metastatic colon cancer in the hepatic phase.
Key inclusion criteria (2 listed)
- Patient with metastatic colon cancer operated on and followed up at the Centre Leon Berard for liver metastasis.
- Patient affiliated to social security
Key exclusion criteria (1 listed)
- Other pathologies that may interfere with biological evaluation, in particular known hepatic cirrhosis, whatever its origin, other liver overload diseases (hemochromatosis, Wilson's disease), but excluding steatosis (which can be chemo-induced).
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 |
|---|---|---|
| Scheduled and planned surgeryCollection of tumour samples from samples collected as part of standard patient management. Diagnostic pathological analysis will be a priority. These samples will be taken by experienced staff during the hospital visit scheduled as part of standard care. | Procedure or surgery | Metastatic colon cancer |
Primary outcome
5-FU in ribosome
Time frame: Up to 24 months
Rate of incorporation of 5-fluorouracil into ribosomes of tumor tissues and adjacent healthy tissues before surgery and after surgery.
3 secondary outcomes
Methylation profile of ribosomal RNAs
Time frame: Up to 24 months
Transcriptomic and proteomic profile
Time frame: Up to 24 months
Specific molecular signature
Time frame: Up to 24 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2024.
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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. This study is not recruiting at the moment.
Philippe CASSIER, MD principal investigator
Centre Leon Berard
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 Cancer of Colon and Metastasis to Liver, run by Centre Leon Berard 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 2 inclusion and 1 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: withdrawn, as of the sponsor's last update on 14 Feb 2024. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
5-FU in ribosome (time frame: Up to 24 months). 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 14 Feb 2024; AzTrials last refreshed its copy on 8 Nov 2026.