Surveillance and Prevention for Cancer Risk

Overseen By Tia Kauffman, MPH

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Dana-Farber Cancer Institute

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

5000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial focuses on individuals who may have a higher risk of developing cancer due to family history or existing conditions. Researchers aim to identify early signs that could predict cancer and prevent it from becoming serious. Participants will provide samples such as blood, saliva, or tissue during regular visits. This trial suits those with a family history of cancer, cancer survivors with past treatments, or anyone showing early-stage cancer signs. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to significant early-stage findings.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It seems that participants with prior cancer history or those receiving therapy for precursor diseases are allowed, so you might not need to stop your medications, but it's best to confirm with the study team.

Why are researchers excited about this trial?

Researchers are excited about this trial because it focuses on cancer prevention and early detection in people who are at a high risk due to hereditary factors or other precursors. Unlike many current approaches that center on treating cancer after it has developed, this trial looks to intercept and prevent cancer by collecting various tissue samples, such as blood and saliva, to monitor changes over time. This proactive strategy aims to identify cancer risks before they manifest into full-blown disease, potentially leading to better outcomes and a higher chance of survival. By involving family members, the trial also seeks to understand genetic influences, offering a more comprehensive approach to cancer prevention.

Who Is on the Research Team?

Sapna Syngal, MD

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

Inclusion Criteria

Exposed High Risk including

1-Hereditary risk for cancer including

Carriers of known or previously unrecognized pathogenic germline variants of cancer predisposing genes

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Sample Collection

Participants provide blood, buccal swabs, urine, stool, biopsy, or other tissue samples for research purposes

Ongoing

Routine visits for sample collection

Follow-up

Participants are monitored for clinical, molecular, and pathological changes to predict cancer development

5 years

Serial follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

• Samples

How Is the Trial Designed?

Group I: PRECURSOR LESIONS Experimental Treatment 1 Intervention

Participants will also be asked to complete an intake survey that will include questions about demographics, medical history and family history data. Tissue samples will be collected during a routine visit. Participants will be asked to donate any of the following tissue types: * Blood * Buccal swab (saliva) or mouthwash * Urine * Stool * Biopsy or surgical tissue (i.e., bone marrow) * Bodily fluids * Other tissues

Group II: HEREDITARY RISK Experimental Treatment 1 Intervention

Participants will also be asked to complete an intake survey that will include questions about demographics, medical history and family history data. Tissue samples will be collected during a routine visit. Participants will be asked to donate any of the following tissue types: * Blood * Buccal swab (saliva) or mouthwash * Urine * Stool * Biopsy or surgical tissue (i.e., bone marrow) * Bodily fluids * Other tissues

Group III: FAMILY MEMBERS Experimental Treatment 1 Intervention

These family members will be identified by the patients participating in the study. Blood, buccal cells, or saliva or oral rinses will be collected in one of three ways from family members of patients (i) at the time of consent; (ii) via a mailed blood kit or saliva kit; or (iii) at a separate appointment scheduled by the consented participant

Group IV: EXPOSED HIGH RISK Experimental Treatment 1 Intervention

Participants will also be asked to complete an intake survey that will include questions about demographics, medical history and family history data. Tissue samples will be collected during a routine visit. Participants will be asked to donate any of the following tissue types: * Blood * Buccal swab (saliva) or mouthwash * Urine * Stool * Biopsy or surgical tissue (i.e., bone marrow) * Bodily fluids * Other tissues

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+