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

Sponsor

Dana-Farber Cancer Institute (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05463796

Collaborator

(none)

5,000

Enrollment

Location

112.8

Anticipated Duration (Months)

44.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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

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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

5000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Nov 1, 2022

Anticipated Primary Completion Date :

Mar 25, 2026

Anticipated Study Completion Date :

Mar 25, 2032

Arms and Interventions

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 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

Outcome Measures

Primary Outcome Measures

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. [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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:

Evidence of symptomatic or active cancer requiring active therapeutic intervention at the time of participation. 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.