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

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.

Study Overview

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

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 5000

Contacts and Locations

• Study Contact: Name: Jenna Beckwith, MPH; Phone Number: 857-215-1892; Email: inadvancestudy@dfci.harvard.edu
• Study Contact Backup: Name: Tia Kauffman, MPH

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Dana Farber Cancer Institute
      • Contact: Sapna Syngal, MD; Phone Number: 617-632-5022; Email: SSYNGAL@PARTNERS.ORG
      • Principal Investigator: Sapna Syngal, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	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 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; 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; 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; 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
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; 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
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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Dana-Farber Cancer Institute
• Investigators: Principal Investigator: Sapna Syngal, MD, Dana-Farber Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2023
• Primary Completion (Estimated): March 25, 2026
• Study Completion (Estimated): March 25, 2032

Study Registration Dates

• First Submitted: June 24, 2022
• First Submitted That Met QC Criteria: July 14, 2022
• First Posted (Actual): July 19, 2022

Study Record Updates

• Last Update Posted (Actual): July 28, 2023
• Last Update Submitted That Met QC Criteria: July 26, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Childhood cancer survivors; Hereditary Risk for Cancer; Adult cancer survivors; Precursor Lesions
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Skin Diseases; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Hematologic Diseases; Gastrointestinal Diseases; Breast Diseases; Musculoskeletal Diseases; Bone Diseases; Esophageal Diseases; Precancerous Conditions; Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Bone Diseases, Developmental; Breast Neoplasms; Osteochondrodysplasias; Neoplasms, Ductal, Lobular, and Medullary; Liver Diseases; Neoplasms; Carcinoma in Situ; Hematologic Neoplasms; Carcinoma; Fatty Liver; Adenoma; Hyperplasia; Non-alcoholic Fatty Liver Disease; Barrett Esophagus; Carcinoma, Lobular; Giant Cell Tumors; Osteochondroma
• Other Study ID Numbers: 22-200

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• IPD Sharing Time Frame: Data can be shared no earlier than 1 year following the date of publication
• IPD Sharing Access Criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No