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Direct Information to At-risk Relatives

Summary

This study evaluates if uptake of genetic counselling in high-risk families is increased when patients at cancer genetics clinics are being offered healthcare-assisted disclosure to at-risk relatives compared to current standard care (with family-mediated disclosure). Patients/families who have undergone a cancer genetic investigation will be invited to participate in the study. All participants will receive standard care. Half of them will in addition be offered a healthcare-assisted disclosure with the service of direct letters to identified at-risk relatives distributed by the healthcare provider. After a year we will compare the proportion of at-risk relatives who have contacted a cancer genetic clinics in each study arm.

Key Facts

Lead Sponsor

Umeå University

Enrollment

490

Start Date

2020-02-06

Completion Date

2023-12-31

Study Type

INTERVENTIONAL

Official Title

Direct Letters to Relatives at Risk of Hereditary Cancer- a Multi-centre Randomised Controlled Trial of Healthcare-assisted Versus Family-mediated Risk Disclosure at Swedish Cancer Genetics Clinics (DIRECT-study)

Interventions

Standard care encouraging family-mediated disclosure of hereditary cancer riskOffer of health-care assisted disclosure by sending direct letters to at-risk relatives

Conditions

Familial Breast CancerFamilial Colorectal CancerHereditary Breast and Ovarian Cancer SyndromeHereditary Breast CancerLynch Syndrome

Eligibility

Age Range

18 Years+

Sex

ALL

Inclusion criteria

1. Patient being offered a cancer genetic investigation for hereditary breast, ovarian or colorectal cancer.
2. Written consent to participate the study,
3. Belonging to a family with; a) familial breast cancer, b) familial colorectal cancer, c) pathogenic variant in PALB2, BRCA1/2 (Hereditary breast cancer, hereditary breast and ovarian cancer), MLH1, MSH2, MSH6, PMS2 (Lynch syndrome) and
4. Having at least one eligible at-risk relative (family member deemed to be an ARR recommended genetic counseling within a year).

Exclusion Criteria:

1. Cannot convey personal opinions and preferences by themselves.
2. No eligible at-risk relatives living in Sweden.

Outcome Measures

Primary Outcomes

Uptake of genetic counselling among the patient's at-risk relatives

Number of potential at-risk relatives who have contacted a Swedish cancer genetic unit out of the total number of potential at-risk relatives for each patient.

Time frame: One year (12 months) following the first counselling session when implications of the cancer genetic investigation for the patient´s at-risk relatives is discussed, hence 12 months after t=0.

Locations

Cancergenetisk mottagning, Umeå, Sweden

Linked Papers

2023-12-17

Direct letters to relatives at risk of hereditary cancer—study protocol for a multi-center randomized controlled trial of healthcare-assisted versus family-mediated risk disclosure at Swedish cancer genetics clinics (DIRECT-study)

Abstract Background The results of germline genetic testing for hereditary cancer are of importance not only to the patients under investigation but also to their genetic at-risk relatives. Standard care is to encourage the proband (first family member under investigation) to pass on this risk information to the relatives. Previous research suggests that with family-mediated disclosure, only about a third of at-risk relatives contact health care to receive genetic counselling. In some studies, complementing family-mediated risk disclosure with healthcare-assisted risk disclosure almost doubles the uptake of genetic counselling in at-risk relatives. In this study, we evaluate healthcare-assisted direct letters to relatives at risk of hereditary cancer syndromes in a randomized controlled trial. Methods Probands are recruited from Swedish outpatient cancer genetics clinics to this two-arm randomized controlled trial. The study recruits probands with either a pathogenic variant in a cancer susceptibility gene ( BRCA1 , BRCA2 , PALB2 , MLH1 , MSH2 , MSH6 , PMS2 ) or probands with familial breast and colorectal cancer based on clinical and pedigree criteria. In both arms, probands receive standard care, i.e., are encouraged and supported to pass on information to relatives. In the intervention arm, the proband is also offered to have direct letters sent to the at-risk relatives. The primary outcome measure is the proportion of at-risk relatives contacting a Swedish cancer genetics clinic within 12 months of the proband receiving the test results. Discussion This paper describes the protocol of a randomized controlled clinical trial evaluating a healthcare-assisted approach to risk disclosure by offering the probands to send direct letters to their at-risk relatives. The results of this study should be informative in the future development of risk disclosure practices in cancer genetics clinics. Trial registration ClinicalTrials.gov. Identifier NCT04197856 (pre-trial registration on December 13, 2019). Also registered at the website “RCC Cancerstudier i Sverige” as study #86719.

Linked Investigators

Anna Rosén