Carcinoid Neuroendocrine CancerNCT00672269
Study Investigating MEN1 and SDHD in Familial Carcinoid Tumors
An observational study of Carcinoid Neuroendocrine Cancer, run by Rutgers University at 1 site in United States.
Trial summary
There is a high incidence among the first degree relatives of the carcinoid patients, indicating the involvement of genetic components in its initiation and pathogenesis. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Carcinoid Neuroendocrine Cancer
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Jun 2010
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Individuals with carcinoid cancer that report to have a first-degree family member also with carcinoid tumor
Who may be able to join
- Over the age of 18 years
- More than one ,member of a family with a history of biopsy confirmed carcinoid tumor
- English speaking
- Mentally and emotionally capable of answering questions
- Willing and available for study participation
- At least one other family member with carcinoid tumor
Who cannot join
- If you are under the age of 18 years,
- If you are unable to understand or unable to provide informed consent,
- If you have a psychological condition (i.e. depression, anxiety disorder, substance abuse, etc.) which might cause you significant problems in dealing with test results.
Trial locations and contacts
1 site in 1 country.
Changshun Shao, PhD contact
United States1 site, 1 recruiting
- Recruiting
Busch Campus of Rutgers University, Human Genetics Institute
Piscataway, New Jersey, 08854-8082
Changshun Shao, PhD, 732-445-5406, shao@biology.rutgers.edu
Nancy Gardner, PhD, 973-991-1302, gardnern@rutgers.edu
About this study
Official title: A Pilot Study to Investigate Germ-Line MEN1 and SDHD Gene Mutation in Familial Cases of Carcinoid Cancer
There is a high incidence among the first degree relatives of the carcinoid patients, indicating the involvement of genetic components in its initiation and pathogenesis.
Read the detailed description
This proposed pilot study will conduct detailed interviews into the medical, environmental, and family histories and to collect blood specimen to obtain DNA. The Blood specimen and DNA will be processed by the Rutgers University Cell and DNA Repository (RUCDR) to rule out Familial Multiple Endocrine Neoplasia (MEN 1), and succinate dehydrogenase complex, subunit D (SDHD), gene inactivation thought to be associated with different types of carcinoid cancer.
- Conditions
- Carcinoid Neuroendocrine Cancer
- Keywords
- carcinoid, family members, familial, tumors, cancer
- Medical subject headings
- Carcinoid Tumor, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Families with carcinoid in multiple family members |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mutations in MEN1 and SDHD genes
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2008 (estimated)
- Study startApr 2008
- Primary completionApr 2009 (estimated)
- Study completionJun 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoid Neuroendocrine CancerStudies of the same condition, open and under way.
- 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-control
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rutgers University
- Sponsor type
- University, hospital or other
- Investigators
- Nancy Gardner, PhD, Principal investigator, Rutgers UniversityChangshun Shao, PhD, Principal investigator, Rutgers University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00672269
- Sponsor's protocol ID
- 08-451
- Status last verified
- Feb 2009
- First submitted
- 2 May 2008
- Last updated
- 4 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Investigate Germ-Line MEN1 and SDHD Gene Mutation in Familial Cases of Carcinoid Cancer
- ClinicalTrials.gov ID
- NCT00672269
- Acronym / sponsor ID
- 08-451
- Conditions
- Carcinoid Neuroendocrine Cancer
- Keywords
- carcinoid, family members, familial, tumors, cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Rutgers UniversityUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Apr 2009 (estimated)
- Study completion
- Jun 2010 (estimated)
- First posted
- 6 May 2008 (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.
There is a high incidence among the first degree relatives of the carcinoid patients, indicating the involvement of genetic components in its initiation and pathogenesis.
Detailed description
This proposed pilot study will conduct detailed interviews into the medical, environmental, and family histories and to collect blood specimen to obtain DNA. The Blood specimen and DNA will be processed by the Rutgers University Cell and DNA Repository (RUCDR) to rule out Familial Multiple Endocrine Neoplasia (MEN 1), and succinate dehydrogenase complex, subunit D (SDHD), gene inactivation thought to be associated with different types of carcinoid cancer.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Families with carcinoid in multiple family members |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Individuals with carcinoid cancer that report to have a first-degree family member also with carcinoid tumor
Key inclusion criteria (6 listed)
- Over the age of 18 years
- More than one ,member of a family with a history of biopsy confirmed carcinoid tumor
- English speaking
- Mentally and emotionally capable of answering questions
- Willing and available for study participation
Key exclusion criteria (3 listed)
- If you are under the age of 18 years,
- If you are unable to understand or unable to provide informed consent,
- If you have a psychological condition (i.e. depression, anxiety disorder, substance abuse, etc.) which might cause you significant problems in dealing with test results.
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
Mutations in MEN1 and SDHD genes
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2009.
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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.
Changshun Shao, PhD contact
Nancy Gardner, PhD principal investigator
Rutgers University
Changshun Shao, PhD principal investigator
Rutgers University
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 Carcinoid Neuroendocrine Cancer, run by Rutgers University at 1 site in United States.
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 3 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 4 Feb 2009. 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 United States. 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 Nancy Gardner, PhD (813-731-0894, gardnern@rutgers.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mutations in MEN1 and SDHD genes (time frame: 1 year). 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 4 Feb 2009.