Carcinoid CarcinomaNCT00662168
An Investigation of Small Intestinal Carcinoid Carcinoma in Families
An observational study of Carcinoid Carcinoma, run by Rutgers University at 1 site in United States.
Trial summary
This proposed pilot study is to conduct detailed interviews into the medical, environmental, and family histories The second phase of this study project is to and to collect blood specimen to obtain DNA. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Carcinoid Carcinoma
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Nov 2008
- 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 family member also with carcinoid tumor
Who may be able to join
- Over the age of 18 years
- History of biopsy confirmed small intestinal carcinoid tumor
- English speaking
- Mentally and emotionally capable of answering questions
- Willing and available for study participation
- At least one first-degree family member with carcinoid tumor
Who cannot join
- If you are under the age of 18 years,
- If you have any mental or memory impairments
- If you are unable to understand the information in the informed consent document.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Rutgers University College of Nursing
Newark, New Jersey, 07102
Nancy Gardner, PhD, 973-991-1302, gardnern@rutgers.edu
Nancy Gardner, PhD
About this study
Official title: An Investigation of Eight Reported Cases of Small Intestinal Carcinoid Carcinoma in Multiple Family Members
This proposed pilot study is to conduct detailed interviews into the medical, environmental, and family histories The second phase of this study project is to 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) and stored for a second phase of this pilot. The purpose is 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.
Read the detailed description
There have not been any studies published which specifically describe the medical, environmental, and genetic factors in carcinoid tumors cases that have carcinoid in family members. While rare, with an incidence of four per 100, 000, carcinoid represents the most frequent malignancy affecting the small intestine. Because nearly half (49%) of the cases of gastrointestinal carcinoid tumors have hepatic metastasis at diagnosis, identification of the risk factors associated with carcinoid has the potential to increase early diagnosis and cure. Carcinoid tumors are thought to occur spontaneously and not associated with an inherited genetic abnormality that would increase a family member's risk for developing carcinoid cancer. There is a known inherited genetic abnormality that is associated with bronchial carcinoid tumors but only less than 10%. Gastrointestinal carcinoid tumors are not thought to be associated with a inherited genetic abnormality. There have been several small studies that have examined gastrointestinal carcinoid in multiple family members. It remains uncertain if these cases of carcinoid in multiple family members are characteristic of a heritable or environmental etiology. Most carcinoid cancer is not inherited; however, less than 10% of neuroendocrine carcinoid cancer is thought to be due to a change (called a "mutation") in a gene inherited from a parent. There are several genes that are suspected to be associated with carcinoid cancer, two of interest in this study is the Multiple Endocrine Neoplasia Type1 (MEN1), and succinate dehydrogenase complex, subunit D (SDHD) genes.
- Conditions
- Carcinoid Carcinoma
- Keywords
- carcinoid, familial, Collect and describe information about the medical and environmental factors associated with each cases of carcinoid carcinoma, Develop a genogram representing the family cancer history of cases of Carcinoid.
- Medical subject headings
- Carcinoid Tumor
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 |
|---|---|---|
| observation | Individuals with a diagnosis of carcinoid carcinoma |
What is being measured
The primary outcome is the main question the study is designed to answer.
identification of carcinoid in multiple family members
Measured: lifetime history
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2008 (estimated)
- Study startJan 2008
- Primary completionNov 2008 (estimated)
- Study completionNov 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoid CarcinomaStudies 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 only
- Time perspective
- Retrospective
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rutgers University
- Sponsor type
- University, hospital or other
- Investigators
- Nancy Gardner, PhD, Principal investigator, Rutgers University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00662168
- Sponsor's protocol ID
- 08-151
- Status last verified
- Apr 2008
- First submitted
- 17 Apr 2008
- Last updated
- 21 Apr 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation of Eight Reported Cases of Small Intestinal Carcinoid Carcinoma in Multiple Family Members
- ClinicalTrials.gov ID
- NCT00662168
- Acronym / sponsor ID
- 08-151
- Conditions
- Carcinoid Carcinoma
- Keywords
- carcinoid, familial, Collect and describe information about the medical and environmental factors associated with each cases of carcinoid carcinoma, Develop a genogram representing the family cancer history of cases of Carcinoid.
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Rutgers UniversityUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Nov 2008 (estimated)
- Study completion
- Nov 2008 (estimated)
- First posted
- 21 Apr 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.
This proposed pilot study is to conduct detailed interviews into the medical, environmental, and family histories The second phase of this study project is to 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) and stored for a second phase of this pilot. The purpose is 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.
Detailed description
There have not been any studies published which specifically describe the medical, environmental, and genetic factors in carcinoid tumors cases that have carcinoid in family members. While rare, with an incidence of four per 100, 000, carcinoid represents the most frequent malignancy affecting the small intestine. Because nearly half (49%) of the cases of gastrointestinal carcinoid tumors have hepatic metastasis at diagnosis, identification of the risk factors associated with carcinoid has the potential to increase early diagnosis and cure. Carcinoid tumors are thought to occur spontaneously and not associated with an inherited genetic abnormality that would increase a family member's risk for developing carcinoid cancer. There is a known inherited genetic abnormality that is associated with bronchial carcinoid tumors but only less than 10%. Gastrointestinal carcinoid tumors are not thought to be associated with a inherited genetic abnormality. There have been several small studies that have examined gastrointestinal carcinoid in multiple family members. It remains uncertain if these cases of carcinoid in multiple family members are characteristic of a heritable or environmental etiology. Most carcinoid cancer is not inherited; however, less than 10% of neuroendocrine carcinoid cancer is thought to be due to a change (called a "mutation") in a gene inherited from a parent. There are several genes that are suspected to be associated with carcinoid cancer, two of interest in this study is the Multiple Endocrine Neoplasia Type1 (MEN1), and succinate dehydrogenase complex, subunit D (SDHD) genes.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| observation | – | –Individuals with a diagnosis of carcinoid carcinoma |
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 family member also with carcinoid tumor
Key inclusion criteria (6 listed)
- Over the age of 18 years
- History of biopsy confirmed small intestinal 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 have any mental or memory impairments
- If you are unable to understand the information in the informed consent document.
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
identification of carcinoid in multiple family members
Time frame: lifetime history
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2008.
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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.
Nancy Gardner, 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 Carcinoma, 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 21 Apr 2008. 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 (973-991-1302, gardnern@rutgers.edu or nancymgardner@msn.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
identification of carcinoid in multiple family members (time frame: lifetime history). 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 21 Apr 2008.