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

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

Recruiting
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Phase N/A

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Overview

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.

Description

The objective of this protocol is to obtain clinical information and facilitate the collection and distribution of specimens obtained during the course of clinical care or research participation.

  • Blood, buccal swabs, urine or tissue or other body fluids (including stool) may be specifically acquired for research in order to perform molecular and other types of analyses for research purposes.
  • These materials will be collected from all eligible participants who have a precursor lesion or an increased risk of cancer

It is expected that about 5,000 people will take part in this research study.

Eligibility

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 including
    • Breast: ductal/lobular carcinoma in situ (CIS) and atypical hyperplasia
    • GI: Barrett's esophagus, Pancreatic precursor lesions, colonic dysplasia/adenomata, nonalcoholic fatty liver (NAFL), nonalcoholic steatohepatitis (NASH), cirrhosis
    • GU: High grade prostatic epithelial neoplasia, and high-grade bladder urothelial dysplasia/carcinoma in situ,
    • Lung: Adenomatous hyperplasia
    • H&N: high-risk oral precancerous diseases
    • Skin: Class II melanocytic lesions. Squamous dysplasia
    • Heme malignancies: CHIP, CCUS, ICUS, MGUS, SMM, SWM, MBL (spell these out), Low grade lymphomas
    • Thoracic: Lung nodules detected on screening CT that prompt further follow-up
    • GYN: STIC lesion (serous tubal intraepithelial carcinoma), Endometrial intraepithelial neoplasia, Cervical and endocervical carcinoma in situ, vulvar intraepithelial neoplasia
    • Pediatric histologic diagnoses sometimes associated with development of malignancy: Nephrogenic rests, benign bone lesions with risk of malignant degeneration (Giant cell tumor, osteochondroma), Spitz nevus, and others.
  • FAMILY MEMBERS or healthy individuals

Exclusion Criteria:

There are no exclusion criteria for the study.

        Note: Patients with prior cancer history are allowed to participate. Patients with prior
        history of cancer or non-metastatic localized cancers (such as skin cancer or localized
        prostate cancer) are allowed to be enrolled. Patients enrolled in clinical trials or
        receiving therapy for precursor diseases are NOT excluded from this study.

Study details
    Cancer 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

NCT05463796

Dana-Farber Cancer Institute

27 January 2024

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FAQs

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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