NCT04257045|Completed
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Sponsor study identifier
Secondary identifiers
REGISTRY · CTRP (Clinical Trial Reporting Program)
OTHER · M D Anderson Cancer Center
observational
46
1 country
2
Study Start
August 21, 2019
Actual (reported)Primary Completion
July 9, 2024
Actual (reported)Study Completion
July 9, 2024
Actual (reported)This trial collects information about factors that affect communication of genetic test results, decision-making, and access to genetic testing in women with hereditary gynecological cancers. Studying individuals who are positive for a genetic mutation and immediate biological family members (including a parent, full-sibling, or child) may help identify cancer genes and other persons at risk.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 9, 2024
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 21, 2019
Actual (reported)February 4, 2020
Actual (reported)February 5, 2020
Actual (reported)July 9, 2024
Actual (reported)July 9, 2024
Actual (reported)Factors influencing decision-making and communication of genetic test results (Step 1)
Up to 3 years
Rates of cascade testing among first-degree relatives (Step 2)
Will be calculated using summary statistics. Will construct a generalized linear mixed model (GLMM) with a logit link function to estimate rate of cascade testing among first-degree relatives.
Up to 3 years
Genetic testing rate (Step 2)
Will construct a model with no predictors and will calculate the probability of genetic testing using the model's intercept as well as calculate the 95% confidence interval of this probability. Will then test factors associated with testing rates (including site \[Lyndon B. Johnson Hospital (LBJ) vs. MD Anderson (MDA)\], socioeconomic, demographic, medical history, and determinants) by including these as independent variables in our GLMMs.
STEP I: Patients and first degree relatives participate in semi-structure, in-depth interviews about genetic testing over 45-60 minutes. STEP II: Patients and first degree relatives complete survey questionnaires over 20 minutes.
Participate in semi-structure, in-depth qualitative interviews
Complete questionnaires
Patients currently receiving diagnostic, treatment, or follow-up care in the outpatient Gynecologic Oncology and Medical Oncology clinics at Lyndon B. Johnson Hospital (LBJ), and their first-degree relatives.
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, 35233, United States
M D Anderson Cancer Center
Houston, Texas, 77030, United States
Jose A Rauh-Hain
M.D. Anderson Cancer Center
46 participants (actual enrollment reported by the registry).
First Submitted
February 4, 2020
First Posted
February 5, 2020
Study Start
August 21, 2019
Actual (reported)Time From Onset of Fever to Administration of Antibiotics in Neutropenic Fever Patients
Up to 3 years
Frequency of reported barriers (Step 2)
Up to 3 years
Complete survey
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
July 9, 2024
Actual (reported)Study Completion
July 9, 2024
Actual (reported)Last Updated
July 12, 2024
Record last verified: 2024-07
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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