InAdvance: Surveillance, Prevention, And Interception In A Population At Risk For Cancer

Study Overview

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.

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.

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

OTHER: Samples

22-200

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2022-06-24	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2024-07-30
First Submitted that Met QC Criteria 2022-07-14	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-07-31
First Posted (ACTUAL) 2022-07-19	Results First Posted N/A	Last Verified 2024-07

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
: 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 th	OTHER: Samples 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 ti
: 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 th	OTHER: Samples 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 ti
: 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 th	OTHER: Samples 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 ti
: 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 ki	OTHER: Samples 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 ti

Primary Outcome Measures	Measure Description	Time Frame
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

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Jenna Beckwith, MPH

Phone Number: 857-215-1892

Email: inadvancestudy@dfci.harvard.edu

Study Contact Backup

Name: Tia Kauffman, MPH

Phone Number:

Email:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:

Accepts Healthy Volunteers:
1

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):

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Sapna Syngal, MD, Dana-Farber Cancer Institute

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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