Recruiting

Genetic Testing

Sponsor:

Brigham and Women's Hospital

Code:

NCT07787156

Conditions

Pancreatic Ductal Adenocarcinoma (PDAC)

Family History of Pancreas Cancer

Genetic Testing

Multi-cancer Early Detection

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Telephone education session

Online educational materials

Study Details

Brief summary:

This study will test a remote approach to help people who may be at higher risk for pancreatic cancer learn about and decide whether to get genetic testing and a blood test that looks for signs of several cancers (MCED testing). The study is focused on Black, Latino/a, and Medicaid-enrolled individuals who may have had less access to cancer genetics and early detection services. About 80 participants, who reside in Massachusetts, will be assigned by chance to receive either online education alone or online education plus a phone call with a trained educator from the Pancreatic Cancer Action Network (PanCAN). After the education, participants can choose whether or not to have genetic testing and/or MCED testing. The main goal is to learn whether this approach is practical to carry out, acceptable to participants, and delivered as planned. Participants will complete 3 surveys during study participation.

Conditions

Pancreatic Ductal Adenocarcinoma (PDAC)

Family History of Pancreas Cancer

Genetic Testing

Multi-cancer Early Detection

Study ID

NCT07787156

Start date

Oct 15, 2026

Status verified date

Oct, 2026

Completion date

Mar, 2029

Anticipated

Primary completion date

Sep, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Aged 50 years or older OR 10 years younger than the earliest PDAC diagnosis in a family member
  • Current Medicaid enrollment and/or Black and/or Latino/a
  • Willingness to travel to Dana-Farber Cancer Institute in Boston, MA, for diagnostic testing if MCED screening test indicates possible malignancy
  • Living in the state of Massachusetts
  • No prior multi-gene panel genetic testing related to PDAC genetic risk
  • Internet access to complete study surveys
  • English speaking
  • Willing to complete study surveys
  • At least one first-degree relative with a PDAC diagnosis by participant report OR Any blood relative with a known pathogenic or likely pathogenic variant in a cancer susceptibility gene related to PDAC by participant report (e.g. ATM, BRCA1, BRCA2, CDKN2A, EPCAM, MLH1, MSH2, MSH6, PALB2, STK11, or TP53)

Exclusion Criteria:

  • Less than age 50 years or age not within 10 years of the earliest PDAC diagnosis in their family
  • Cancer diagnosis in the last 3 years (excluding non-melanoma skin cancers)
  • Currently pregnant
  • Insurance other than Medicaid or race/ethnicity other than Black or Latino/a
  • Prior genetic testing related to PDAC genetic risk
  • Genetic counseling in the last 3 years
  • Living in a state other than Massachusetts
  • Language other than English
  • Three members of the same family already enrolled in the study

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Telephone education session plus online educational materials

Participants will receive information about genetic testing and MCED testing through a telephone education session, in addition to receiving emailed links to online educational materials from the testing company.

active comparator: Online educational materials only

Participants will be emailed links to online educational materials from the testing company

Interventions

Telephone education session

Participants will receive a telephone call from a trained navigator at PanCAN to provide \~20mins of information about genetic testing and MCED testing.

Online educational materials

Participants will receive links to test information provided by the testing company.

Primary outcome measure

  • Feasibility of completion of genetic testing and MCED testing [ Time Frame: Within 6 months of randomization ]
  • Acceptability of the education delivery [ Time Frame: Within 6 months of the educational information ]
  • Fidelity of the intervention [ Time Frame: Assessed within 6 months of the education session ]

Central Contacts and Locations

Central contacts

Tia Kauffman, MPH

857-215-1892tial_kauffman@dfci.harvard.edu

Jenna Beckwith, MPH

857-215-1892JennaB_Beckwith@dfci.harvard.edu

Locations

Dana-Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Ishmarie Colon-Rivera

857-215-1892regeneratestudy@dfci.harvard.edu

Jenna Beckwith, MPH

857-215-1892JennaB_Beckwith@dfci.harvard.edu

Principal Investigator:

Nicolette J Rodriguez, MD, MPH

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

Oct 22, 2026

Last verified

Oct, 2026

Keywords

  • Pancreatic cancer
  • Pancreas cancer
  • Family history of pancreatic cancer
  • Pancreatic ductal adenocarcinoma (PDAC)
  • Genetic testing
  • Genetic education
  • Multi-cancer Early Detection (MCED) education

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2026-10-22. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.