NCT03897374

Brief Summary

The primary goal of the study is to record data over the observation period to evaluate the clinical benefit of using hereditary cancer genomic diagnostics to assess overall hereditary genetic cancer risk profile and to help guide physicians to pursue preventative measures, which may lead to early detection and treatment of the condition.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120,000

participants targeted

Target at P75+ for all trials

Timeline
32mo left

Started Mar 2025

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress30%
Mar 2025Dec 2028

First Submitted

Initial submission to the registry

March 26, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 1, 2019

Completed
6 years until next milestone

Study Start

First participant enrolled

March 26, 2025

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

March 19, 2026

Status Verified

March 1, 2026

Enrollment Period

3.8 years

First QC Date

March 26, 2019

Last Update Submit

March 17, 2026

Conditions

Early Detection of Cancer

Outcome Measures

Primary Outcomes (2)

  • Genomic cancer screen

    A study subject is known to have personal and/or family history of cancer known to be influenced by genetic variation.

    120 Days

  • Genomic cancer screen

    A genotype known to be a predisposition for cancer.

    120 Days

Interventions

Genetic TestingDIAGNOSTIC_TEST

Buccal swab

Eligibility Criteria

Age65 Years+
Sexall
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Individuals, ages 65 years or older.

You may qualify if:

  • individuals, ages 65 years or older;
  • must have met medical necessity for hereditary cancer genomic testing and allowed the physician to test based on medical necessity;
  • hereditary cancer diagnostic test was ordered by a physician related to individual subject care considerations.
  • study subject has or had cancer
  • study subject has at least one family member with cirrent or past cancer

You may not qualify if:

  • Study subjects will be excluded from the study if any of the following criteria apply: • study subject is currently hospitalized or incarcerated;
  • study subject is unable to provide an accurate history due to mental incapacity
  • study subject is currently abusing illicit and/or prescription drugs;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sunbeam Clinical

Prosper, Texas, 75078, United States

RECRUITING

MeSH Terms

Interventions

Genetic Testing

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesGenetic TechniquesGenetic ServicesHealth ServicesHealth Care Facilities Workforce and ServicesDiagnostic ServicesPreventive Health Services

Central Study Contacts

C David, MBA

CONTACT

7174671201stopcancer@callmdglobal.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
120 Days
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2019

First Posted

April 1, 2019

Study Start

March 26, 2025

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

March 19, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)