Rectum CancerBASE HSP110NCT02458664
BASE HSP110 : A New Therapeutic Target and a New Marker for Prognosis of Type MSI Colorectal Cancer
An observational study of Rectum Cancer and Cancer of Colon, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
We collect prospectively and retrospectively, patients' demographic, pathological, surgical, therapeutic and prognosis informations in a database. After patient's consent to collect tumoural samples of their colorectal cancer after resection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectum Cancer, Cancer of Colon
- What is being tested?
- Genetic analysis on tumor kept in tumor bank
- How many people
- 597 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2013to Nov 2018
- 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, male or female, over 18 years, undergoing curative colorectal resection
Who may be able to join
- All patients undergoing curative colorectal cancer in general and digestive surgery department at Saint-Antoine hospital.
- Patients reporting their non-opposition to the use of tissue samples taken from their specimen for research purposes.
Who cannot join
- Patients who did not report their non-opposition to the use of tissue samples taken from their specimen for research purposes.
Trial locations and contacts
1 site in 1 country.
France1 site
Department of Digestive Surgery, Hôpital Saint-Antoine
Paris, France, 75012
About this study
We collect prospectively and retrospectively, patients' demographic, pathological, surgical, therapeutic and prognosis informations in a database. After patient's consent to collect tumoural samples of their colorectal cancer after resection.
We will then be able to evaluate the impact of HSP110, a chaperon protein, on their prognosis. Other proteins (to be determined) will also be study, after.
Read the detailed description
To investigate the importance of HSP110DE9 as a prognostic marker for colorectal cancer, we will analyze genotyping fluorescence quantitative RT-PCR and / or immunomarquage the presence of this mutant in a large cohort of patients (more than 2000 patients had or having a colorectal cancer). All patients have been or will be made in general and digestive surgery department at Saint-Antoine hospital. Tumor fragments samples were or will be made on their tumor and keep it in the tumor bank of the Saint-Antoine hospital. All patients reported their no objection to the use of these tumor fragments for research purposes. A database will be built and correlated with the tumor fragments. This project is intended that the constitution of a clinical database including prognostic so that we make discoveries on HSP110DE9 or other molecular biology to discover markers can be correlated with clinical data. In the absence of other studies on the subject, with no real knowledge of the prognostic impact of this mutant, we cannot provide an effective computation. We therefore propose to make a database of 2000 patients retrospectively and prospectively to obtain statistical results valid and powerful.
- Conditions
- Rectum Cancer, Cancer of Colon
- Being tested
- Genetic analysis on tumor kept in tumor bank
- Medical subject headings
- Rectal Neoplasms, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genetic analysis on tumor kept in tumor bankGenetic
| Study group | Role | What they receive |
|---|---|---|
| Colo-rectal cancer | All patients undergoing curative colorectal cancer in general and digestive surgery department at Saint-Antoine hospital Receives: Genetic: Genetic analysis on tumor kept in tumor bank |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence free survival and Recurrence free survival after resection of the colon cancer
3 years for prospective patients, more for retrospective patients
Measured: End of follow up : at least 3 years
Secondary outcomes (1)
Overall survival
3 years for prospective patients, more for retrospective patients
Measured: End of follow up : at least 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2015 (estimated)
- Study startNov 2013
- Primary completionNov 2018 (estimated)
- Study completionNov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectum CancerStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Enrolment
- 597 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02458664
- Sponsor's protocol ID
- NI12029
- Other IDs
- 2013-A01080-45
- Acronym
- BASE HSP110
- Status last verified
- Nov 2015
- First submitted
- 27 May 2015
- Last updated
- 2 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BASE HSP110 : A New Therapeutic Target and a New Marker for Prognosis of Type MSI Colorectal Cancer
- ClinicalTrials.gov ID
- NCT02458664
- Acronym / sponsor ID
- BASE HSP110 / NI12029
- Conditions
- Rectum Cancer, Cancer of Colon
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 597 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- Nov 2013
- Primary completion
- Nov 2018 (estimated)
- Study completion
- Nov 2018 (estimated)
- First posted
- 1 Jun 2015 (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.
We collect prospectively and retrospectively, patients' demographic, pathological, surgical, therapeutic and prognosis informations in a database. After patient's consent to collect tumoural samples of their colorectal cancer after resection.
We will then be able to evaluate the impact of HSP110, a chaperon protein, on their prognosis. Other proteins (to be determined) will also be study, after.
Detailed description
To investigate the importance of HSP110DE9 as a prognostic marker for colorectal cancer, we will analyze genotyping fluorescence quantitative RT-PCR and / or immunomarquage the presence of this mutant in a large cohort of patients (more than 2000 patients had or having a colorectal cancer). All patients have been or will be made in general and digestive surgery department at Saint-Antoine hospital. Tumor fragments samples were or will be made on their tumor and keep it in the tumor bank of the Saint-Antoine hospital. All patients reported their no objection to the use of these tumor fragments for research purposes. A database will be built and correlated with the tumor fragments. This project is intended that the constitution of a clinical database including prognostic so that we make discoveries on HSP110DE9 or other molecular biology to discover markers can be correlated with clinical data. In the absence of other studies on the subject, with no real knowledge of the prognostic impact of this mutant, we cannot provide an effective computation. We therefore propose to make a database of 2000 patients retrospectively and prospectively to obtain statistical results valid and powerful.
Study design
- Observational model
- Cohort
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Colo-rectal cancer | – | Genetic: Genetic analysis on tumor kept in tumor bankAll patients undergoing curative colorectal cancer in general and digestive surgery department at Saint-Antoine hospital |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients, male or female, over 18 years, undergoing curative colorectal resection
Key inclusion criteria (2 listed)
- All patients undergoing curative colorectal cancer in general and digestive surgery department at Saint-Antoine hospital.
- Patients reporting their non-opposition to the use of tissue samples taken from their specimen for research purposes.
Key exclusion criteria (1 listed)
- Patients who did not report their non-opposition to the use of tissue samples taken from their specimen for research purposes.
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 |
|---|---|---|
| Genetic analysis on tumor kept in tumor bank | Genetic | Colo-rectal cancer |
Primary outcome
Recurrence free survival and Recurrence free survival after resection of the colon cancer
Time frame: End of follow up : at least 3 years
3 years for prospective patients, more for retrospective patients
1 secondary outcome
Overall survival
Time frame: End of follow up : at least 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Rectum Cancer and Cancer of Colon, run by Assistance Publique - Hôpitaux de Paris 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: status not confirmed, as of the sponsor's last update on 2 Dec 2015. 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?
Results are not available in the source record.
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?
Recurrence free survival and Recurrence free survival after resection of the colon cancer (time frame: End of follow up : at least 3 years). 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 2 Dec 2015.