- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04890327
Web-based Family History Tool (Progeny)
Clinical Utility of a Web-based Tool for Collection of Family Health History and Risk-assessment in Patients Presenting to a Gynecologic Oncology Clinic
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10065
- Weill Cornell Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Female > 18 years of age. Scheduled for new patient visit with one of the gynecologic oncologists at Weill Cornell Medicine (Melissa Frey MD, Kevin Holcomb MD, Evelyn Cantillo MD, Eloise Chapman MD).
Exclusion Criteria:
Subjects who cannot communicate in English as the FHH collection tool and surveys are available only in English.
Subjects who were adopted and have no information about their family health history.
Subjects who do not present for the new patient visit.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Standard of Care
Patient presents to new Gynecologic Oncology appointment, family health history is collected by the physician during the clinic visit.
Both the subject and physician complete assessment survey at the completion of clinic visit.
Subject's medical record reviewed 6 months following study enrollment to determine subject's diagnosis, whether or not subject underwent genetic counseling and/or genetic testing and review genetic testing results.
|
|
Experimental: Office
Patient presents to new Gynecologic Oncology appointment, subject is given access to a desk top computer in office and instructed to complete web-based family health history tool.
Physician reviews results of patients web-based family health history tool.Subject and physician complete assessment survey at the completion of clinic visit.
Subject's medical record reviewed 6 months following study enrollment to determine subject's diagnosis, whether or not subject underwent genetic counseling and/or genetic testing and review genetic testing results.
|
Web-based tool that collects subject's family health history through a series of questions and generates a pedigree which documents a risk assessment report for the physician to use.
The risk assessment report uses standard, validated risk scores including GAIL , CLAUS, BRCAPRO which measure breast cancer risk, and MMRPRO which measures endometrial cancer risk, MELAPRO which measures melanoma cancer risk, and PANCPRO which measures pancreatic cancer risk
|
Experimental: Home
Patient is emailed a link containing web-based family health history tool prior to presenting for new Gynecologic Oncology appointment.
Physician reviews results of patients web-based family health history tool.
Subject and physician complete assessment survey at the completion of clinic visit.
Subject's medical record reviewed 6 months following study enrollment to determine subject's diagnosis, whether or not subject underwent genetic counseling and/or genetic testing and review genetic testing results.
|
Web-based tool that collects subject's family health history through a series of questions and generates a pedigree which documents a risk assessment report for the physician to use.
The risk assessment report uses standard, validated risk scores including GAIL , CLAUS, BRCAPRO which measure breast cancer risk, and MMRPRO which measures endometrial cancer risk, MELAPRO which measures melanoma cancer risk, and PANCPRO which measures pancreatic cancer risk
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of subjects with high quality family health history (FHH)
Time Frame: Anytime between 18 - 24 months
|
To compare the amount of subjects with a high quality family health history in each of the study arms that properly assesses disease risk. Currently FHH in a gynecologic oncology clinic setting is inadequate to assess disease risk. The use of a web-based FHH collection tool that also offers the providers with a risk assessment tool may address these challenges and increase the comprehensiveness of FHH collection and risk assessment in the gynecologic oncology clinic. For a pedigree to be considered high quality, at least one individual in the pedigree must meet all quality criteria ("high quality relative").
|
Anytime between 18 - 24 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 1612017795
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Breast Cancer
-
Northwestern UniversityEisai Inc.UnknownMale Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative...United States
-
Rutgers, The State University of New JerseyNational Cancer Institute (NCI); Rutgers Cancer Institute of New JerseyActive, not recruitingStage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative Breast CancerUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedMale Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
-
University of WashingtonTerminatedBreast Cancer | Breast Cancer Stage I | Breast Cancer Stage II | Breast Cancer Stage III | Breast Cancer Stage IIB | Breast Cancer Stage IIA | Breast Cancer Stage IIIA | Breast Cancer Stage IIIB | Breast Cancer Stage IIIcUnited States
-
CelgeneCompletedBreast Cancer | Metastatic Breast Cancer | Stage IV Breast Cancer | Triple-negative Breast Cancer | Recurrent Breast Cancer | Breast Tumor | Cancer of the Breast | Triple-negative Metastatic Breast Cancer | Estrogen Receptor- Negative Breast Cancer | HER2- Negative Breast Cancer | Progesterone Receptor- Negative...United States, United Kingdom, Italy, Germany, Spain, Canada, Portugal, Australia, Austria, Greece, Brazil, France
-
University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedHER2-positive Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
-
University of WashingtonNational Cancer Institute (NCI)CompletedHER2-positive Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Estrogen Receptor-negative Breast Cancer | Estrogen Receptor-positive Breast Cancer | Progesterone Receptor-negative Breast Cancer | Progesterone Receptor-positive Breast...United States
-
University of WashingtonNational Cancer Institute (NCI)CompletedHER2-positive Breast Cancer | Male Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
-
Sidney Kimmel Cancer Center at Thomas Jefferson...Susan G. Komen Breast Cancer FoundationCompletedStage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative Breast CancerUnited States
-
Baylor Breast Care CenterRecruitingBreast Cancer | Breast Neoplasm | Triple Negative Breast Cancer | Triple Negative Breast Neoplasms | HER2-positive Breast Cancer | Breast Cancer Stage II | Breast Cancer Female | Breast Cancer Stage III | Estrogen Receptor-positive Breast Cancer | Hormone Receptor-positive Breast Cancer | Breast Cancer InvasiveUnited States
Clinical Trials on Web-based family health history tool
-
H. Lee Moffitt Cancer Center and Research InstituteRecruitingReproductive BehaviorUnited States
-
Bournemouth UniversityPoole Hospital NHS Foundation TrustCompletedAdvanced Pancreatic CancerUnited Kingdom
-
VA Office of Research and DevelopmentCompletedColorectal CancerUnited States
-
Mackay Medical CollegeTaipei Veterans General Hospital, TaiwanCompletedBreast Neoplasm Female | Fertility PreservationTaiwan
-
University of PittsburghCompletedUsability | Acceptability | Intervention ComplianceUnited States
-
Vanderbilt UniversityCompletedObesityUnited States
-
Northwestern UniversityUniversity of Alabama at BirminghamCompleted
-
Michigan State UniversityRecruitingHereditary DiseasesUnited States
-
Brigham and Women's HospitalCompletedHealth Status | Family Research | Family CharacteristicsUnited States
-
Mackay Medical CollegeTaipei Veterans General Hospital, TaiwanCompletedBreast Neoplasm Female