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

ConditionsCancer Risk Cancer Predisposition Syndrome Hereditary Cancer Prediction Childhood Cancer Survivors Adult Cancer Survivors IARC Carcinogens Smoking History Lung Cancer Ductal/Lobular Carcinoma Barrett Esophagus Pancreatic Precursor Lesions Colonic Dysplasia/Adenomata Non-Alcoholic Fatty Liver Disease Non Alcoholic Steatohepatitis Cirrhosis High Grade Prostatic Epithelial Neoplasia High-grade Bladder Urothelial Dysplasia/Carcinoma in Situ Adenomatous Hyperplasia High-risk Oral Precancerous Diseases Melanocytic Lesion, Adult Hematologic Malignancy Lung; Node Serous Tubal Intraepithelial Carcinoma Endometrial Intraepithelial Neoplasia Cervical and Endocervical Carcinoma in Situ Vulvar Intraepithelial Neoplasia Nephrogenic Rests Benign Bone Lesions With Risk of Malignant Degeneration Giant Cell Tumor Osteochondroma Spitz Nevus

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

AgeNot listed

SponsorDana-Farber Cancer Institute

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial population

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 Hereditary risk for cancer, Exposed High Risk, Precursor Lesions, FAMILY MEMBERS

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Samples
Other intervention
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

Treatment groups

5,000 Participants

are divided into 4 treatment groups

Group A: HEREDITARY RISK1 intervention

Group B: EXPOSED HIGH RISK1 intervention

Group C: PRECURSOR LESIONS1 intervention

Group D: FAMILY MEMBERS1 intervention

Trial outcomes

Primary outcomes

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 InAdvance Study will screen participants for precancerous conditions and cancer through blood tests and tissue biopsies. These biologic samples will be screened for precancerous conditions through routine clinical methods, as well as using novel research level technology. This could include germline testing, whole genome and whole exome sequencing. The participants will be followed serially to track their disease progression. Participants will fill out general health questionnaires, and we will match their answers to the timepoint of their sample submission and follow changes to their answers.

Time frame

5 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Dana-Farber Cancer Institute

Lead sponsor

Source ClinicalTrials.gov

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