Malignant NeoplasmNCT02337452
Web-Based Family Outreach Program for Cancer Prevention in High-Risk Families
An observational study of Malignant Neoplasm, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This trial develops a patient-driven self-navigated web-based family outreach program for cancer prevention in high-risk families. Creating the family outreach program may help to improve the way in which genetic test results are communicated within families and increase the number of at-risk relatives who become… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Malignant Neoplasm
- What is being tested?
- Questionnaire Administration and Web Site
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Apr 2015to 30 Apr 2048
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants with genetic abnormalities and their families at MD Anderson Cancer Center in Houston, Texas
Who may be able to join
- Individuals who have been diagnosed with a hereditary cancer-causing mutation. Individuals may be identified through clinical testing as patients at MD Anderson or patients whose mutation was identified at an outside institution who contact the registry
- Individuals that have clinical suspicion for syndromic cancer susceptibility, but in whom mutational testing has been nondiagnostic (depending on condition in question, nondiagnostic testing may be as little as 10%, as in familial adenomatous polyposis [FAP], or as high as 70% in suspected hereditary diffuse gastric cancer or HDGC)
- At-risk family members of individuals with a cancer causing mutation or of individuals with nondiagnostic testing notwithstanding presence of likely syndromic cancer. Such patients will in most cases not be MD Anderson patients. Note: The enrollment, consenting, and evaluation process anticipates and addresses this.
Who cannot join
- Index patients who test negative for a cancer causing mutation, except for those agreeing to provide family history (FH) that is informative for at-risk individuals when no other source of such information is available
- Patients who are unwilling or are unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Patient-Driven Self-Navigated Web-Based Family Outreach Program for Cancer Prevention in High-Risk Families
This trial develops a patient-driven self-navigated web-based family outreach program for cancer prevention in high-risk families. Creating the family outreach program may help to improve the way in which genetic test results are communicated within families and increase the number of at-risk relatives who become aware of their risks.
Read the detailed description
PRIMARY OBJECTIVES:
- To develop a secure, web-based program for family outreach in Clinical Cancer Genetics (CCG).
II. The long-term goals of this program are expected to include, but are not limited to the following:
IIa. To enable families with inherited cancer susceptibility and/or at increased familial risk of cancer to provide personal and family history of neoplasia through a convenient and self-directed program.
IIb. To enable communication of possible inherited cancer susceptibility with and among family members through the web-based portal.
IIc. To facilitate genetic testing, screening and prevention strategies in those at risk.
IId. Establish high-risk cohort for optional participation in research and clinical trials.
OUTLINE:
Patients communicate with at-risk family members to share genetic test results and other relevant information, as well as to learn more about their disease via family outreach program website. At risk family members are then contacted by a study coordinator or genetic counselor for further follow-up. At-risk relatives receive resources to facilitate understanding of their at-risk status and to facilitate predictive testing.
- Conditions
- Malignant Neoplasm
- Being tested
- Questionnaire Administration, Web Site
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire AdministrationOther
Ancillary studies
Web SiteBehavioural
Also called Internet Website, Website, www-website
Communicate via family outreach program website
| Study group | Role | What they receive |
|---|---|---|
| Observational (family outreach program) | Patients communicate with at-risk family members to share genetic test results and other relevant information, as well as to learn more about their disease via family outreach program website. At risk family members are then contacted by a study coordinator or genetic counselor for further follow up. At-risk relatives receive resources to facilitate understanding of their at-risk status and to facilitate predictive testing. Receives: Other: Questionnaire Administration; Behavioral: Web Site |
What is being measured
The primary outcome is the main question the study is designed to answer.
Web-Based Family Outreach Registry
Data analysis for core functions of the web-based Family Outreach Registry will generally be descriptive. Web-based program to improve the way in which genetic test results are communicated within families and to increase the number of at-risk relatives who become aware of their risks.
Measured: Continual assessment of data over participant's life time (target follow-up duration: 40 Years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2015 (estimated)
- Study start10 Apr 2015
- Primary completion30 Apr 2048 (estimated)
- Study completion30 Apr 2048 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant NeoplasmStudies 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
- Family based
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Selvi Thirumurthi, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02337452
- Sponsor's protocol ID
- 2014-0715
- Other IDs
- NCI-2020-00567, 2014-0715, P30CA016672
- Status last verified
- Oct 2026
- First submitted
- 9 Jan 2015
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Patient-Driven Self-Navigated Web-Based Family Outreach Program for Cancer Prevention in High-Risk Families
- ClinicalTrials.gov ID
- NCT02337452
- Acronym / sponsor ID
- 2014-0715
- Conditions
- Malignant Neoplasm
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 10 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 10 Apr 2015 (actual)
- Primary completion
- 30 Apr 2048 (estimated)
- Study completion
- 30 Apr 2048 (estimated)
- First posted
- 13 Jan 2015 (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 trial develops a patient-driven self-navigated web-based family outreach program for cancer prevention in high-risk families. Creating the family outreach program may help to improve the way in which genetic test results are communicated within families and increase the number of at-risk relatives who become aware of their risks.
Detailed description
PRIMARY OBJECTIVES:
- To develop a secure, web-based program for family outreach in Clinical Cancer Genetics (CCG).
II. The long-term goals of this program are expected to include, but are not limited to the following:
IIa. To enable families with inherited cancer susceptibility and/or at increased familial risk of cancer to provide personal and family history of neoplasia through a convenient and self-directed program.
IIb. To enable communication of possible inherited cancer susceptibility with and among family members through the web-based portal.
IIc. To facilitate genetic testing, screening and prevention strategies in those at risk.
IId. Establish high-risk cohort for optional participation in research and clinical trials.
OUTLINE:
Patients communicate with at-risk family members to share genetic test results and other relevant information, as well as to learn more about their disease via family outreach program website. At risk family members are then contacted by a study coordinator or genetic counselor for further follow-up. At-risk relatives receive resources to facilitate understanding of their at-risk status and to facilitate predictive testing.
Study design
- Observational model
- Family based
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational (family outreach program) | – | Other: Questionnaire Administration, Behavioral: Web SitePatients communicate with at-risk family members to share genetic test results and other relevant information, as well as to learn more about their disease via family outreach program website. At risk family members are then contacted by a study coordinator or genetic counselor for further follow up. At-risk relatives receive resources to facilitate understanding of their at-risk status and to facilitate predictive testing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with genetic abnormalities and their families at MD Anderson Cancer Center in Houston, Texas
Key inclusion criteria (3 listed)
- Individuals who have been diagnosed with a hereditary cancer-causing mutation. Individuals may be identified through clinical testing as patients at MD Anderson or patients whose mutation was identified at an outside institution who contact the registry
- Individuals that have clinical suspicion for syndromic cancer susceptibility, but in whom mutational testing has been nondiagnostic (depending on condition in question, nondiagnostic testing may be as little as 10%, as in familial adenomatous polyposis [FAP], or as high as 70% in suspected hereditary diffuse gastric cancer or HDGC)
- At-risk family members of individuals with a cancer causing mutation or of individuals with nondiagnostic testing notwithstanding presence of likely syndromic cancer. Such patients will in most cases not be MD Anderson patients. Note: The enrollment, consenting, and evaluation process anticipates and addresses this.
Key exclusion criteria (2 listed)
- Index patients who test negative for a cancer causing mutation, except for those agreeing to provide family history (FH) that is informative for at-risk individuals when no other source of such information is available
- Patients who are unwilling or are unable to 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 |
|---|---|---|
| Questionnaire AdministrationAncillary studies | Other | Observational (family outreach program) |
| Web SiteAlso: Internet Website, Website, www-websiteCommunicate via family outreach program website | Behavioural | Observational (family outreach program) |
Primary outcome
Web-Based Family Outreach Registry
Time frame: Continual assessment of data over participant's life time (target follow-up duration: 40 Years)
Data analysis for core functions of the web-based Family Outreach Registry will generally be descriptive. Web-based program to improve the way in which genetic test results are communicated within families and to increase the number of at-risk relatives who become aware of their risks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- 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.
Selvi Thirumurthi 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 Malignant Neoplasm, 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 2 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: under way, not looking for participants, as of the sponsor's last update on 6 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Web-Based Family Outreach Registry (time frame: Continual assessment of data over participant's life time (target follow-up duration: 40 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 6 Oct 2026.