RecruitingNot Applicable

InAdvance: Surveillance, Prevention, and Interception in a Population at Risk for Cancer

United States5,000 participantsStarted 2023-04-25

Plain-language summary

This research study is creating a way to collect and store specimens and information from participants who may be at an increased risk of developing cancer, or has been diagnosed with an early phase of a cancer or a family member who has a family member with a precursor condition for cancer. * The objective of this study is to identify exposures as well as clinical, molecular, and pathological changes that can be used to predict early development of cancer, malignant transformation, and risks of progression to symptomatic cancer that can ultimately be fatal. * The ultimate goal is to identify novel markers of early detection and risk stratification to drive potential therapeutic approaches to intercept progression to cancer.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Participants to be included in this study include the following (note that this list is not comprehensive but gives examples of precursor conditions for each organ type): 1-Hereditary risk for cancer including * Carriers of known or previously unrecognized pathogenic germline variants of cancer predisposing genes * Individuals with personal or family history suggestive of elevated cancer risk (this may include individuals who have negative genetic testing results or have not elected to undergo testing) * Individuals with a clinically based diagnosis of a Cancer Predisposition Syndrome (examples, neurofibromatosis, Fanconi Anemia, Ataxia-Telangiectasia) * Hereditary Cancer Prediction Model-based elevated cancer risk * Others at risk for specific cancers by virtue of exposure, obesity, gender, race and ethnicity, HPV exposure (for H\&N cancer for example), etc. * Exposed High Risk including * Childhood cancer survivors with treatment exposures associated with increased risk of cancer * Adult cancer survivors with treatment exposures associated with increased risk of cancer * Documented high level exposure to group 1 IARC carcinogens * Thoracic: individuals at risk for lung cancer including but not exclusive of the following criteria: Age \>50, Smoking history of \>15 pack years, First-degree relative history of lung cancer or COPD * alcoholic liver disease (NAFL), non-alcoholic steatohepatitis (NASH), cirrhosis * Precursor Lesions …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Given that this trial seems to cover a wide range of cancer risk categories — from hereditary syndromes to precancerous lesions like Barrett's esophagus or colonic adenomas — does my specific condition or risk factor actually fit the kind of population they're studying, and would my doctor think this is worth exploring?
2Since this trial is classified as 'Phase NA,' which suggests it's more of an observational or surveillance study than one testing a new treatment, does that mean I wouldn't be receiving any experimental therapy, and would this replace or run alongside my current standard care plan?
3This study is trying to identify early molecular and clinical changes that predict cancer development — so what kinds of tests, biopsies, imaging, or sample collections might I be asked to undergo, and how often would I need to come in over the course of the study?
4Because this trial focuses on prediction and interception rather than treating an existing cancer, would participating in it actually change any decisions my care team makes about my monitoring or treatment, or would the data mainly benefit future patients?
5Are there any risks specific to the extra surveillance procedures or sample collection involved in this study that I should weigh against the potential benefit of being more closely monitored for early cancer changes?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Identify exposures as well as clinical, molecular, and pathological changes that can be used to predict early development of cancer, malignant transformation, and risks of progression to symptomatic cancer that can ultimately be fatal.

Timeframe: 5 years

Trial details

NCT IDNCT05463796

SponsorDana-Farber Cancer Institute

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-03-25

Contact for this trial

Jenna Beckwith, MPH

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

View on ClinicalTrials.gov More Cancer Risk trials

Plain-language summary

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.