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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05463796
• Other study ID #: 22-200
• Status: Recruiting
• Start date: April 25, 2023
• Est. completion date: March 25, 2032

Study information

• Verified date: July 2023
• Source: Dana-Farber Cancer Institute
• Contact: Jenna Beckwith, MPH
• Phone: 857-215-1892
• Email: inadvancestudy[@]dfci.harvard.edu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: March 25, 2032
• Est. primary completion date: March 25, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Adenoma
• Barrett Esophagus
• Cancer Risk
• Carcinoma
• Carcinoma in Situ
• Carcinoma, Lobular
• Childhood Cancer Survivors
• Cirrhosis
• Endometrial Intraepithelial Neoplasia
• Fatty Liver
• Giant Cell Tumors
• Hematologic Malignancy
• Hematologic Neoplasms
• Hyperplasia
• Liver Diseases
• Lung Cancer
• Lung; Node
• Neoplasms
• Non Alcoholic Steatohepatitis
• Non-Alcoholic Fatty Liver Disease
• Vulvar Intraepithelial Neoplasia

Intervention

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

Locations

Country	Name	City	State
United States	Dana Farber Cancer Institute	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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