Recruiting

NCT Number: NCT05463796

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

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.

Recruiting

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Key information

Conditions

Cancer Risk Adenocarcinoma Adenomatous Hyperplasia Adult Cancer Survivors Barrett Esophagus Benign Bone Lesions With Risk of Malignant Degeneration Bone Diseases Bone Diseases, Developmental Breast Diseases Breast Neoplasms Cancer Predisposition Syndrome Carcinoma Carcinoma in Situ Carcinoma, Lobular Cervical and Endocervical Carcinoma in Situ Childhood Cancer Survivors Cirrhosis Colonic Dysplasia/Adenomata Digestive System Diseases Ductal/Lobular Carcinoma Endometrial Hyperplasia Endometrial Intraepithelial Neoplasia Esophageal Diseases Fatty Liver Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Fibrosis Gastrointestinal Diseases Genital Diseases Genital Diseases, Female Giant Cell Tumor Giant Cell Tumors Hematologic Diseases Hematologic Malignancy Hematologic Neoplasms Hemic and Lymphatic Diseases Hereditary Cancer Prediction High Grade Prostatic Epithelial Neoplasia High-grade Bladder Urothelial Dysplasia/Carcinoma in Situ High-risk Oral Precancerous Diseases IARC Carcinogens Liver Diseases Lung Cancer Lung Diseases Lung Neoplasms Lung; Node Melanocytic Lesion, Adult Musculoskeletal Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Bone Tissue Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms, Ductal, Lobular, and Medullary Neoplasms, Glandular and Epithelial Nephrogenic Rests Nevi and Melanomas Nevus Nevus, Epithelioid and Spindle Cell Nevus, Pigmented Nevus, Spindle Cell Non Alcoholic Steatohepatitis Non-Alcoholic Fatty Liver Disease Osteochondrodysplasias Osteochondroma Pancreatic Precursor Lesions Pathologic Processes Pathological Conditions, Signs and Symptoms Precancerous Conditions Respiratory Tract Diseases Respiratory Tract Neoplasms Serous Tubal Intraepithelial Carcinoma Skin Diseases Skin and Connective Tissue Diseases Smoking History Spitz Nevus Thoracic Neoplasms Urogenital Diseases Uterine Diseases Vulvar Intraepithelial Neoplasia

Sex eligibility

All sexes

Study type

Observational

Primary location

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location status: Recruiting

Location contact

Sapna Syngal, MD

CONTACT

[email protected]

617-632-5022

Sapna Syngal, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Samples

Other

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

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.

Time frame: 5 years

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jenna Beckwith, MPH

CONTACT

[email protected]

857-215-1892

Tia Kauffman, MPH

CONTACT

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Registry information

Important dates

Study start: 2023
Primary completion: 2027
Study completion: 2032
First posted: Jul 19, 2022
Registry last updated: Aug 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Recruiting