Small Intestinal Carcinoid TumorsNCT03622333
Clinic, Pathologic and Genetic Characterization of Patients With Familial Carcinoid Tumors (Study From the GTE, Groupe d'étude Des Tumeurs Endocrines)
A study testing Research of constitutional genetic alterations in people with Small Intestinal Carcinoid Tumors, run by CHU de Reims at 1 site in France.
Trial summary
Small intestine carcinoid tumors are rare. Small intestine Familial Carcinoid Tumors (FCT) are defined by the occurrence of at least 2 cases of this tumor type in first- or second-degree relatives. The estimated prevalence of FCT is 2.6%-3.7% in patients with small intestine carcinoid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Intestinal Carcinoid Tumors
- What is being tested?
- Research of constitutional genetic alterations
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 28 May 2018to 28 Nov 2022
- 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
- Small-intestine (or ascending colon or appendix) neuroendocrine tumor (proven histologically)
- At least one first- or second-degree relative with a small-intestine (or ascending colon or appendix) neuroendocrine tumor (proven histologically)
- Agreement to participate to the study exclusion criteria :
- Subjects unable to provide consent
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Louis DE MESTIER contact
France1 site, 1 recruiting
- Recruiting
Damien JOLLY
Reims
Guillaume CADIOT, 03 26 78 84 41, gcadiot@chu-reims.fr
About this study
Small intestine carcinoid tumors are rare. Small intestine Familial Carcinoid Tumors (FCT) are defined by the occurrence of at least 2 cases of this tumor type in first- or second-degree relatives. The estimated prevalence of FCT is 2.6%-3.7% in patients with small intestine carcinoid tumors. Because of its rarity, epidemiologic, clinic and pathologic features of FCT have been scarcely described. Molecular abnormalities associated with FCT have been poorly explored. Constitutional genetic factors predisposing to FCT have not been discovered to date. Only one abnormality (mutation of the IPMK gene) has been reported in one FCT family only, but not found in other series.
The main objective of this study is to identify the constitutional factors predisposing to small-intestine FCT (and other midgut localizations: ascending colon and appendix). The secondary objectives are to describe the clinic and pathologic features associated with FCT.
- Conditions
- Small Intestinal Carcinoid Tumors
- Being tested
- Research of constitutional genetic alterations
- Keywords
- Neuroendocrine tumors, carcinoid tumors, midgut, small intestine, genetic predisposition, hereditary
- Medical subject headings
- Neuroendocrine Tumors, Carcinoid Tumor, Genetic Predisposition to Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Research of constitutional genetic alterationsGenetic
Tumor DNA extraction Blood sample and constitutional DNA extraction CGH-array, Exome sequencing Bio-informatic analysis
| Study group | Role | What they receive |
|---|---|---|
| Familial Carcinoid Tumors | Experimental | All patients with proven Familial Carcinoid Tumors Receives: Genetic: Research of constitutional genetic alterations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Deletion
Quantitative Constitutional genetic alterations detected by comparative genomic hybridization (CGH array)
Measured: day 0
duplication
Quantitative Constitutional genetic alterations detected by comparative genomic hybridization (CGH array)
Measured: Day 0
amplification
Quantitative Constitutional genetic alterations detected by comparative genomic hybridization (CGH array)
Measured: Day 0
mutation
qualitative Constitutional genetic alterations detected by NGS (Next Generation Sequencing)
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2018
- Study start28 May 2018
- Primary completion28 May 2022 (estimated)
- Study completion28 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Intestinal Carcinoid TumorsStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03622333
- Sponsor's protocol ID
- PO18020
- Status last verified
- Feb 2018
- First submitted
- 22 Feb 2018
- Last updated
- 20 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinic, Pathologic and Genetic Characterization of Patients With Familial Carcinoid Tumors (Study From the GTE, Groupe d'étude Des Tumeurs Endocrines)
- ClinicalTrials.gov ID
- NCT03622333
- Acronym / sponsor ID
- PO18020
- Conditions
- Small Intestinal Carcinoid Tumors
- Keywords
- Neuroendocrine tumors, carcinoid tumors, midgut, small intestine, genetic predisposition, hereditary
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- 28 May 2018 (actual)
- Primary completion
- 28 May 2022 (estimated)
- Study completion
- 28 Nov 2022 (estimated)
- First posted
- 9 Aug 2018 (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.
Small intestine carcinoid tumors are rare. Small intestine Familial Carcinoid Tumors (FCT) are defined by the occurrence of at least 2 cases of this tumor type in first- or second-degree relatives. The estimated prevalence of FCT is 2.6%-3.7% in patients with small intestine carcinoid tumors. Because of its rarity, epidemiologic, clinic and pathologic features of FCT have been scarcely described. Molecular abnormalities associated with FCT have been poorly explored. Constitutional genetic factors predisposing to FCT have not been discovered to date. Only one abnormality (mutation of the IPMK gene) has been reported in one FCT family only, but not found in other series.
The main objective of this study is to identify the constitutional factors predisposing to small-intestine FCT (and other midgut localizations: ascending colon and appendix). The secondary objectives are to describe the clinic and pathologic features associated with FCT.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Familial Carcinoid Tumors | Experimental | Genetic: Research of constitutional genetic alterationsAll patients with proven Familial Carcinoid Tumors |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Small-intestine (or ascending colon or appendix) neuroendocrine tumor (proven histologically)
- At least one first- or second-degree relative with a small-intestine (or ascending colon or appendix) neuroendocrine tumor (proven histologically)
- Agreement to participate to the study exclusion criteria :
- Subjects unable to provide consent
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Research of constitutional genetic alterationsTumor DNA extraction Blood sample and constitutional DNA extraction CGH-array, Exome sequencing Bio-informatic analysis | Genetic | Familial Carcinoid Tumors |
Primary outcome
Deletion
Time frame: day 0
Quantitative Constitutional genetic alterations detected by comparative genomic hybridization (CGH array)
duplication
Time frame: Day 0
Quantitative Constitutional genetic alterations detected by comparative genomic hybridization (CGH array)
amplification
Time frame: Day 0
Quantitative Constitutional genetic alterations detected by comparative genomic hybridization (CGH array)
mutation
Time frame: Day 0
qualitative Constitutional genetic alterations detected by NGS (Next Generation Sequencing)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2018.
Related trials for Small Intestinal Carcinoid Tumors
Recruiting
Virtual Reality for GI Cancer Pain to Improve Patient Reported Outcomes
Cancer Pain, Visceral Pain
Active, not recruitingPhase 2
Study of Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-3475-158/KEYNOTE-158)
Advanced Cancer, Anal Carcinoma
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.
Louis DE MESTIER contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Research of constitutional genetic alterations in people with Small Intestinal Carcinoid Tumors, run by CHU de Reims 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 4 inclusion and 0 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 20 Aug 2018. 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?
Contact Guillaume CADIOT (03 26 78 84 41, gcadiot@chu-reims.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Deletion (time frame: day 0). The study lists 4 primary outcomes in all. 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 20 Aug 2018.