Clinical trial NCT05463796: InAdvance: Surveillance, Prevention, and Interception in a Population at Risk for Cancer
Official title: InAdvance: Surveillance, Prevention, and Interception in a Population at Risk For Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
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 Nevus
Keywords: Hereditary Risk for Cancer
Childhood cancer survivors
Adult cancer survivors
Precursor Lesions
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
First posted: 2022-07-19
Enrollment: 5000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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.

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.

Primary outcomes:
measure: 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.
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Sapna Syngal, MD
role: PRINCIPAL_INVESTIGATOR
References: