Lynch SyndromeNCT00633607
Hereditary Colorectal and Associated Tumor Registry Study
An observational study of Lynch Syndrome and FAP, run by University of Pittsburgh at 1 site in United States.
Trial summary
After informed consent, participants will be asked to complete a medical/family history questionnaire and provide a blood sample. Participants will also be asked for their permission for study investigators to access medical records and/or recontact them for updates to their medical and family histories. Read more about this study
- Who is it for?
- Ages 8 to 100 years
- Conditions the study is for
- Lynch Syndrome, FAP, Hereditary Diffuse Gastric Cancer
- What is being tested?
- Research Registry
- How many people
- 114 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to 26 Jan 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 8 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Potential research subjects are recruited from our Hereditary GI clinic.
Who may be able to join
- Identified gene mutation
- Personal history of colorectal cancer diagnosed ≤ 50
- Personal history of cancer with tumor studies suggestive of Lynch syndrome
- Personal history of multiple primary tumors associated with a hereditary cancer syndrome (colorectal, uterus, stomach, ovary, small bowel, hepatobiliary tract, transitional cell carcinoma of the renal pelvis/ureter, brain)
- Personal history of one of the above cancers and a family history of one or more of the above cancers
- Personal or family history of diffuse gastric cancer
Show all 10Show fewer
- From a known genetic predisposition family
- Personal history of > 10 colon adenomas (cumulative over a lifetime)
- Personal history of any number of hamartomatous polyps
- Personal history of multiple large (> 1cm) serrated polyps to right of sigmoid
Who cannot join
- Individuals under the age of 8
- Individuals who cannot travel to Pittsburgh for in-person enrollment
- Individuals who cannot provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15232
About this study
After informed consent, participants will be asked to complete a medical/family history questionnaire and provide a blood sample. Participants will also be asked for their permission for study investigators to access medical records and/or recontact them for updates to their medical and family histories. Data and biospecimens will be stored for potential future research projects.
- Conditions
- Lynch Syndrome, FAP, Hereditary Diffuse Gastric Cancer, Juvenile Polyposis Syndrome, Peutz-Jeghers Syndrome
- Being tested
- Research Registry
- Medical subject headings
- Colorectal Neoplasms, Hereditary Nonpolyposis, Stomach Neoplasms, Juvenile polyposis syndrome, Peutz-Jeghers Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Research RegistryOther
Information regarding medical and family history is stored in the registry to be used for potential future studies
What is being measured
The primary outcome is the main question the study is designed to answer.
Establish a Hereditary Colorectal Tumor Registry to facilitate development and implementation of epidemiological, clinical and cancer control research.
Measured: 1-N/A (up to 8 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2008 (estimated)
- Study startApr 2012
- Primary completion26 Jan 2018
- Study completion26 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lynch SyndromeStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Family based
- Time perspective
- Other
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Randall Brand, University of Pittsburgh
- Investigators
- Randall E Brand, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00633607
- Sponsor's protocol ID
- 04-112
- Status last verified
- Feb 2018
- First submitted
- 3 Mar 2008
- Last updated
- 19 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hereditary Colorectal and Associated Tumor Registry Study
- ClinicalTrials.gov ID
- NCT00633607
- Acronym / sponsor ID
- 04-112
- Conditions
- Lynch Syndrome, FAP, Hereditary Diffuse Gastric Cancer, Juvenile Polyposis Syndrome, Peutz-Jeghers Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- 26 Jan 2018 (actual)
- Study completion
- 26 Jan 2018 (actual)
- First posted
- 12 Mar 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.
After informed consent, participants will be asked to complete a medical/family history questionnaire and provide a blood sample. Participants will also be asked for their permission for study investigators to access medical records and/or recontact them for updates to their medical and family histories. Data and biospecimens will be stored for potential future research projects.
Study design
- Observational model
- Family based
- Time perspective
- Other
Who may qualify
- Ages
- 8 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Potential research subjects are recruited from our Hereditary GI clinic.
Key inclusion criteria (10 listed)
- Identified gene mutation
- Personal history of colorectal cancer diagnosed ≤ 50
- Personal history of cancer with tumor studies suggestive of Lynch syndrome
- Personal history of multiple primary tumors associated with a hereditary cancer syndrome (colorectal, uterus, stomach, ovary, small bowel, hepatobiliary tract, transitional cell carcinoma of the renal pelvis/ureter, brain)
- Personal history of one of the above cancers and a family history of one or more of the above cancers
Key exclusion criteria (3 listed)
- Individuals under the age of 8
- Individuals who cannot travel to Pittsburgh for in-person enrollment
- Individuals who cannot provide informed consent
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 RegistryInformation regarding medical and family history is stored in the registry to be used for potential future studies | Other | – |
Primary outcome
Establish a Hereditary Colorectal Tumor Registry to facilitate development and implementation of epidemiological, clinical and cancer control research.
Time frame: 1-N/A (up to 8 years)
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 Feb 2018.
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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.
Randall E Brand, MD principal investigator
University of Pittsburgh
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 Lynch Syndrome and FAP, run by University of Pittsburgh 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 10 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: finished, as of the sponsor's last update on 19 Feb 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 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?
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?
Establish a Hereditary Colorectal Tumor Registry to facilitate development and implementation of epidemiological, clinical and cancer control research. (time frame: 1-N/A (up to 8 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 19 Feb 2018.