InAdvance: Surveillance, Prevention, and Interception in a Population at Risk for 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 NevusSummary
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.
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.
Locations
1 location Found with status Recruiting
Status
- RECRUITING
Contact Person
- Sapna Syngal, MD
- 617-632-5022
- [email protected]
Principal Investigator
- Sapna Syngal, MD
Eligibility Criteria
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
HEREDITARY RISK
Participants will also be asked to complete an intake survey that will include questions about demographics, medical history and family history data.nnTissue samples will be collected during a routine visit.nnParticipants will be asked to donate any of the following tissue types:nn* Bloodn* Buccal swab (saliva) or mouthwashn* Urinen* Stooln* Biopsy or surgical tissue (i.e., bone marrow)n* Bodily fluidsn* Other tissues
OTHER:
SamplesDescription:
Tissue samples will be collected during a routine visit. Participants will be asked to donate any of the following tissue types:nnBlood, 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.nnTissue samples will be collected during a routine visit.nnParticipants will be asked to donate any of the following tissue types:nn* Bloodn* Buccal swab (saliva) or mouthwashn* Urinen* Stooln* Biopsy or surgical tissue (i.e., bone marrow)n* Bodily fluidsn* Other tissues
OTHER:
SamplesDescription:
Tissue samples will be collected during a routine visit. Participants will be asked to donate any of the following tissue types:nnBlood, 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.nnTissue samples will be collected during a routine visit.nnParticipants will be asked to donate any of the following tissue types:nn* Bloodn* Buccal swab (saliva) or mouthwashn* Urinen* Stooln* Biopsy or surgical tissue (i.e., bone marrow)n* Bodily fluidsn* Other tissues
OTHER:
SamplesDescription:
Tissue samples will be collected during a routine visit. Participants will be asked to donate any of the following tissue types:nnBlood, 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:
SamplesDescription:
Tissue samples will be collected during a routine visit. Participants will be asked to donate any of the following tissue types:nnBlood, 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.
Timeline
Last Updated
July 31, 2024Start Date
July 19, 2022Today
February 5, 2025Completion Date ( Estimated )
March 25, 2032
Sponsors of this trial
Lead Sponsor
Dana-Farber Cancer Institute