Colorectal NeoplasmsNCT01577511
Invasiveness and Chemoresistance of Cancer Stem Cells in Colon Cancer
An observational study of Colorectal Neoplasms, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
The main objective of this study is to identify and characterize subpopulations of cells with invasive capacity in colorectal cancer from primary tumor, blood and metastatic samples. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Neoplasms
- What is being tested?
- Samples and follow up
- Type of treatment
- Injection or infusion
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 12 Jun 2012to 31 Dec 2016
- 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: Patients with operable, stage III or IV, adenocarcino-type colorectal cancer treated at the Nîmes University Hospital.
Who may be able to join
- The patient must have given his/her informed and signed consent
- The patient must be insured or beneficiary of a health insurance plan
- Patient with adenocarcinoma-type colorectal cancer:
- stage III at diagnosis, surgical resection of the primary tumor proposed.
- stage IV at diagnosis, surgical resection of the primary tumor and possibly of metastases proposed.
- Stage IV who have already undergone surgical excision of the primary tumor, and for whom metastasectomy is now proposed.
Who cannot join
- The patient is participating in another study
- The patient is in an exclusion period determined by a previous study
- The patient is under judicial protection, under tutorship or curatorship
- The patient refuses to sign the consent
- It is impossible to correctly inform the patient
- Patients for whom surgical resection of the primary tumor is not considered as an option
- PStage IV at diagnosis, but metastasectomy is not considered as an option
- Patients with positive HIV, Hepatitis B or Hepatitis C serology
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Invasiveness and Chemoresistance of Cancer Stem Cells in Colon Cancer: Molecular Characterization and Implications for Therapeutic Strategies
The main objective of this study is to identify and characterize subpopulations of cells with invasive capacity in colorectal cancer from primary tumor, blood and metastatic samples.
Read the detailed description
Secondary objectives include:
- Determine the intrinsic properties essential for the dissemination and chemoresistance of these cells capable of initiating tumors
- Identify a "molecular signature" for potential invasiveness and chemoresistance of cells initiating metastases.
- Describe the evolution of patients during 24 months of follow up and correlations with observed cellular profiles.
- Enrich the tumor bank of the institution.
- Conditions
- Colorectal Neoplasms
- Being tested
- Samples and follow up
- Keywords
- invasive potential, molecular characterisation of circulating cells
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Samples and follow upBiological
Samples: Peroperative blood sample plus primary and metastatic tumor biopsies.
Follow-up: disease outcomes assessed at 24 months
| Study group | Role | What they receive |
|---|---|---|
| 30 Patients | Patients with operable, stage III or IV, adenocarcino-type colorectal cancer treated at the Nîmes University Hospital.
Intervention: Samples and follow up Receives: Biological: Samples and follow up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability to maintain the cells isolated from colorectal tumors in culture or 3D collagen matrices and then infect these cells to make them express reporter genes: yes/no.
Measured: Baseline (Day 0)
Secondary outcomes (21)
Serology HIV
Measured: baseline; day 0
Serology Hepatitis B
Measured: baseline; day 0
Serology Hepatitis C
Measured: baseline; day 0
Location of primary tumor
right colon, left colon, transverse colon, sigmoid, rectum
Measured: base line; day 0
Age at diagnosis
Measured: baseline, day 0
Metastases from the outset: Yes / No
Measured: baseline, day 0
Resection proposed: yes/no
Measured: baseline, day 0
Chemotherapy proposed? yes/no
Measured: baseline, day 0
Number of metastases
Measured: 24 months
Resection performed: yes/no
Measured: 24 months
Number of chemotherapy sessions performed
Measured: 24 months
Objective tumoral response to treatment? yes/no
Measured: 24 months
Tumor recurrence: yes/no
Measured: 24 months
Vital status
living/deceased
Measured: 24 months
Ability to establish tumor xenografts from injected cells: yes/no.
Measured: baseline; Day 0
Ability to detect subpopulations of tumor cells expressing fluorophores by flow cytometry after isolation: yes/no
Measured: baseline; day 0
Characterization of mRNA expression profiling and micro-RNA + in vitro EMT cells
Measured: baseline; day 0
World Health Organisation Score
Measured: 24 months
Tumor staging
Measured: 24 months
Number of surgeries performed
Measured: 24 months
Number of circulating cancer cells per ml blood
Measured: baseline; day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2012 (estimated)
- Study start12 Jun 2012
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
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 Colorectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe 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 (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-François Bourgaux, MD, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01577511
- Sponsor's protocol ID
- LOCAL/2011/JFB-01
- Other IDs
- 2011-A01141-40
- Status last verified
- Jan 2020
- First submitted
- 12 Apr 2012
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Grillet F, Bayet E, Villeronce O, Zappia L, Lagerqvist EL, Lunke S, Charafe-Jauffret E, Pham K, Molck C, Rolland N, Bourgaux JF, Prudhomme M, Philippe C, Bravo S, Boyer JC, Canterel-Thouennon L, Taylor GR, Hsu A, Pascussi JM, Hollande F, Pannequin J. Circulating tumour cells from patients with colorectal cancer have cancer stem cell hallmarks in ex vivo culture. Gut. 2017 Oct;66(10):1802-1810. doi: 10.1136/gutjnl-2016-311447. Epub 2016 Jul 25.
PubMed 27456153
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Invasiveness and Chemoresistance of Cancer Stem Cells in Colon Cancer: Molecular Characterization and Implications for Therapeutic Strategies
- ClinicalTrials.gov ID
- NCT01577511
- Acronym / sponsor ID
- LOCAL/2011/JFB-01
- Conditions
- Colorectal Neoplasms
- Keywords
- invasive potential, molecular characterisation of circulating cells
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 12 Jun 2012 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 16 Apr 2012 (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 main objective of this study is to identify and characterize subpopulations of cells with invasive capacity in colorectal cancer from primary tumor, blood and metastatic samples.
Detailed description
Secondary objectives include:
- Determine the intrinsic properties essential for the dissemination and chemoresistance of these cells capable of initiating tumors
- Identify a "molecular signature" for potential invasiveness and chemoresistance of cells initiating metastases.
- Describe the evolution of patients during 24 months of follow up and correlations with observed cellular profiles.
- Enrich the tumor bank of the institution.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 30 Patients | – | Biological: Samples and follow upPatients with operable, stage III or IV, adenocarcino-type colorectal cancer treated at the Nîmes University Hospital. Intervention: Samples and follow up |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with operable, stage III or IV, adenocarcino-type colorectal cancer treated at the Nîmes University Hospital.
Key inclusion criteria (6 listed)
- The patient must have given his/her informed and signed consent
- The patient must be insured or beneficiary of a health insurance plan
- Patient with adenocarcinoma-type colorectal cancer:
- stage III at diagnosis, surgical resection of the primary tumor proposed.
- stage IV at diagnosis, surgical resection of the primary tumor and possibly of metastases proposed.
Key exclusion criteria (8 listed)
- The patient is participating in another study
- The patient is in an exclusion period determined by a previous study
- The patient is under judicial protection, under tutorship or curatorship
- The patient refuses to sign the consent
- It is impossible to correctly inform the patient
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 |
|---|---|---|
| Samples and follow upSamples: Peroperative blood sample plus primary and metastatic tumor biopsies. Follow-up: disease outcomes assessed at 24 months | Biological | 30 Patients |
Primary outcome
Ability to maintain the cells isolated from colorectal tumors in culture or 3D collagen matrices and then infect these cells to make them express reporter genes: yes/no.
Time frame: Baseline (Day 0)
21 secondary outcomes
Serology HIV
Time frame: baseline; day 0
Serology Hepatitis B
Time frame: baseline; day 0
Serology Hepatitis C
Time frame: baseline; day 0
Location of primary tumor
Time frame: base line; day 0
Age at diagnosis
Time frame: baseline, day 0
Metastases from the outset: Yes / No
Time frame: baseline, day 0
Resection proposed: yes/no
Time frame: baseline, day 0
Chemotherapy proposed? yes/no
Time frame: baseline, day 0
Number of metastases
Time frame: 24 months
Resection performed: yes/no
Time frame: 24 months
Number of chemotherapy sessions performed
Time frame: 24 months
Objective tumoral response to treatment? yes/no
Time frame: 24 months
Tumor recurrence: yes/no
Time frame: 24 months
Vital status
Time frame: 24 months
Ability to establish tumor xenografts from injected cells: yes/no.
Time frame: baseline; Day 0
Ability to detect subpopulations of tumor cells expressing fluorophores by flow cytometry after isolation: yes/no
Time frame: baseline; day 0
Characterization of mRNA expression profiling and micro-RNA + in vitro EMT cells
Time frame: baseline; day 0
World Health Organisation Score
Time frame: 24 months
Tumor staging
Time frame: 24 months
Number of surgeries performed
Time frame: 24 months
Number of circulating cancer cells per ml blood
Time frame: baseline; day 0
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 19 Nov 2025.
- Results publication: PubMed 27456153Grillet F, Bayet E, Villeronce O, Zappia L, Lagerqvist EL, Lunke S, Charafe-Jauffret E, Pham K, Molck C, Rolland N, Bourgaux JF, Prudhomme M, Philippe C, Bravo S, Boyer JC, Canterel-Thouennon L, Taylor GR, Hsu A, Pascussi JM, Hollande F, Pannequin J. Circulating tumour cells from patients with colorectal cancer have cancer stem cell hallmarks in ex vivo culture. Gut. 2017 Oct;66(10):1802-1810. doi: 10.1136/gutjnl-2016-311447. Epub 2016 Jul 25.
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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.
Jean-François Bourgaux, MD principal investigator
Centre Hospitalier Universitaire de Nīmes
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 Colorectal Neoplasms, run by Centre Hospitalier Universitaire de Nīmes 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 6 inclusion and 8 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 19 Nov 2025. 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 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?
Ability to maintain the cells isolated from colorectal tumors in culture or 3D collagen matrices and then infect these cells to make them express reporter genes: yes/no. (time frame: Baseline (Day 0)). 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 NCT01577511, 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 19 Nov 2025.