Colon CancerNCT00508846
Screening for Gynecologic Cancers in Hereditary Nonpolyposis Colorectal Cancer (HNPCC) Patients
An observational study of Colon Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
Among women with HNPCC, this study will assess: 1. Knowledge of screening recommendations for endometrial and ovarian cancers. 2. Perceived risk and cancer worries regarding endometrial, ovarian and colorectal cancers. 3. Adherence to screening recommendations for endometrial, ovarian and colon cancers. 4. Read more about this study
- Who is it for?
- Ages 25 years and older, women only
- Conditions the study is for
- Colon Cancer
- What is being tested?
- Questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 93 participants
- Where
- 1 siteUnited States
- Study dates
- May 2003to Mar 2016
- 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 25 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women, age 25 years of age or older, diagnosed with Hereditary Non-Polyposis Colon Cancer (HNPCC).
Who may be able to join
- Being female
- Being 25 years of age or older
- Having an HNPCC-predisposing mutation and/or having a family history of cancer that meets the Amsterdam or Amsterdam II criteria for HNPCC
Who cannot join
- Persons who have tested negative for a known HNPCC-predisposing mutation in their family
- Persons who have no family HNPCC mutation and have not met the Amsterdam I/II criteria
- Being younger than 25 years old
- Note: Women who have had a prior history of colorectal cancer or polyps will not be excluded unless they meet one of the above exclusion criteria.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Screening for Gynecologic Cancers Among Women With Hereditary Non-Polyposis Colon Cancer (HNPCC)
Among women with HNPCC, this study will assess:
- Knowledge of screening recommendations for endometrial and ovarian cancers.
- Perceived risk and cancer worries regarding endometrial, ovarian and colorectal cancers.
- Adherence to screening recommendations for endometrial, ovarian and colon cancers.
- Perceived benefits,supports and barriers to endometrial and ovarian cancer screening.
- Patterns of communication about endometrial and ovarian cancer risk within families with HNPCC and with health care providers.
- Patient preferences for potential cancer screening and cancer prevention strategies related to HNPCC-associated cancers.
Read the detailed description
Women who are at risk for HNPCC will be recruited to participate in this pilot study.
Women will be invited to participate in the study either through a mailed invitation or during a visit to M.D. Anderson for clinical services or for research purposes.
Women who wish to participate in the study will complete an informed consent, and will subsequently schedule an appointment with a research coordinator to complete the study questionnaire by telephone.
- Conditions
- Colon Cancer
- Being tested
- Questionnaire
- Keywords
- Hereditary Non-Polyposis Colon Cancer, Gynecologic Cancers, Genetic Counseling, Questionnaire, Survey, HNPCC
- Medical subject headings
- Colonic Neoplasms, Colorectal Neoplasms, Hereditary Nonpolyposis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireBehavioural
Also called Survey
Two-part telephone questionnaire lasting about 60 minutes total.
| Study group | Role | What they receive |
|---|---|---|
| HNPCC Patients | Not described Receives: Behavioral: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Responses to Questionnaire
Outcomes measuring demographics, surveillance behaviors, perceived risk, and cancer worries, screening supports/benefits and barriers.
Measured: 7 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2007 (estimated)
- Study startMay 2003
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Susan Peterson, PhD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00508846
- Sponsor's protocol ID
- ID03-0211
- Status last verified
- Mar 2016
- First submitted
- 26 Jul 2007
- Last updated
- 11 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening for Gynecologic Cancers Among Women With Hereditary Non-Polyposis Colon Cancer (HNPCC)
- ClinicalTrials.gov ID
- NCT00508846
- Acronym / sponsor ID
- ID03-0211
- Conditions
- Colon Cancer
- Keywords
- Hereditary Non-Polyposis Colon Cancer, Gynecologic Cancers, Genetic Counseling, Questionnaire, Survey, HNPCC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- May 2003
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 30 Jul 2007 (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.
Among women with HNPCC, this study will assess:
- Knowledge of screening recommendations for endometrial and ovarian cancers.
- Perceived risk and cancer worries regarding endometrial, ovarian and colorectal cancers.
- Adherence to screening recommendations for endometrial, ovarian and colon cancers.
- Perceived benefits,supports and barriers to endometrial and ovarian cancer screening.
- Patterns of communication about endometrial and ovarian cancer risk within families with HNPCC and with health care providers.
- Patient preferences for potential cancer screening and cancer prevention strategies related to HNPCC-associated cancers.
Detailed description
Women who are at risk for HNPCC will be recruited to participate in this pilot study.
Women will be invited to participate in the study either through a mailed invitation or during a visit to M.D. Anderson for clinical services or for research purposes.
Women who wish to participate in the study will complete an informed consent, and will subsequently schedule an appointment with a research coordinator to complete the study questionnaire by telephone.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HNPCC Patients | – | Behavioral: Questionnaire |
Who may qualify
- Ages
- 25 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women, age 25 years of age or older, diagnosed with Hereditary Non-Polyposis Colon Cancer (HNPCC).
Key inclusion criteria (3 listed)
- Being female
- Being 25 years of age or older
- Having an HNPCC-predisposing mutation and/or having a family history of cancer that meets the Amsterdam or Amsterdam II criteria for HNPCC
Key exclusion criteria (4 listed)
- Persons who have tested negative for a known HNPCC-predisposing mutation in their family
- Persons who have no family HNPCC mutation and have not met the Amsterdam I/II criteria
- Being younger than 25 years old
- Note: Women who have had a prior history of colorectal cancer or polyps will not be excluded unless they meet one of the above exclusion criteria.
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 |
|---|---|---|
| QuestionnaireAlso: SurveyTwo-part telephone questionnaire lasting about 60 minutes total. | Behavioural | HNPCC Patients |
Primary outcome
Patient Responses to Questionnaire
Time frame: 7 Years
Outcomes measuring demographics, surveillance behaviors, perceived risk, and cancer worries, screening supports/benefits and barriers.
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 11 Mar 2016.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
Susan Peterson, PhD principal investigator
M.D. Anderson Cancer Center
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 Colon Cancer, run by M.D. Anderson Cancer Center 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 3 inclusion and 4 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 11 Mar 2016. 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?
Patient Responses to Questionnaire (time frame: 7 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 11 Mar 2016.