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

NCT05463796 | Recruiting

• 1 other identifier: 22-200
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Hereditary Risk for Cancer; Childhood cancer survivors; Adult cancer survivors; Precursor Lesions

Outcome Measures

Primary Outcomes (1)

• 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.

  5 years

Study Arms (4)

HEREDITARY RISK

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

Other: Samples

EXPOSED HIGH RISK

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

Other: Samples

PRECURSOR LESIONS

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

Other: Samples

FAMILY MEMBERS

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

Other: Samples

Interventions

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

EXPOSED HIGH RISK; FAMILY MEMBERS; HEREDITARY RISK; PRECURSOR LESIONS

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study 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

You may qualify if:

• 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 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead

Study Sites (1)

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Patients' specimens including blood, buccal swab or mouthwash, urine, stool, bone marrow, tissue from biopsy or surgical excision, bodily fluids or other specimens will be collected from patients who consent to the protocol.

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Lobular; Barrett Esophagus; Non-alcoholic Fatty Liver Disease; Fibrosis; Carcinoma in Situ; Hematologic Neoplasms; Endometrial Hyperplasia; Giant Cell Tumors; Osteochondroma; Nevus, Epithelioid and Spindle Cell

Interventions

Sampling Studies

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Ductal, Lobular, and Medullary; Breast Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Precancerous Conditions; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Fatty Liver; Liver Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematologic Diseases; Hemic and Lymphatic Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms, Bone Tissue; Osteochondrodysplasias; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Nevus, Spindle Cell; Nevus, Pigmented; Nevus; Nevi and Melanomas

Intervention Hierarchy (Ancestors)

Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Sapna Syngal, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jenna Beckwith, MPH

CONTACT

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

Tia Kauffman, MPH

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 20 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 24, 2022
• First Posted: July 19, 2022
• Study Start: April 25, 2023
• Primary Completion (Estimated): March 25, 2027
• Study Completion (Estimated): March 25, 2032
• Last Updated: August 7, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

Locations

US (1)