Validation of DNA Methylation Markers for Universal and Site-specific Guided Cancer Detection, VANGUARD Study

Description

This study explores the potential value of a new blood test approach for early detection of cancer.

Conditions

Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm

Study Overview

Study Details

Study overview

This study explores the potential value of a new blood test approach for early detection of cancer.

Validation of DNA Methylation Markers for the Universal and Site-Specific Guided Cancer Detection (the VANGUARD Study)

Validation of DNA Methylation Markers for Universal and Site-specific Guided Cancer Detection, VANGUARD Study

Condition
Hematopoietic and Lymphatic System Neoplasm
Intervention / Treatment

-

Contacts and Locations

Rochester

Mayo Clinic in Rochester, Rochester, Minnesota, United States, 55905

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Aim 1 Tissue
  • * Cases:
  • * Patient has a biopsy confirmed diagnosis of target histology
  • * Tissue samples from synchronous or metachronous primary cancers may be used as long as they are clearly of a different target organ.
  • * Tumors from patients with an underlying genetic disorder pre-disposing to cancer may be included as long as they are stratified from those without
  • * Controls:
  • * Patient does not have the diagnosis of target histology
  • * Aim 2 Blood
  • * Cases:
  • * Patient has a biopsy confirmed diagnosis of target histology or radiographic criteria that are unequivocal for diagnosis (example, meets radiographic criteria for hepatocellular carcinoma)
  • * Controls:
  • * Patient does not have a diagnosis of the target histology
  • * Aim 3 Urine
  • * Cases:
  • * Patient has a biopsy confirmed diagnosis of target histology or radiographic criteria that are unequivocal for diagnosis (example, meets radiographic criteria for hepatocellular carcinoma)
  • * Controls:
  • * Patient does not have a diagnosis of the target histology
  • * Aim 1 Tissue
  • * Cases and Controls:
  • * Patient has had any transplants prior to tissue collection
  • * Patient has received chemotherapy class drugs within 5 years prior to tissue collection
  • * Cases:
  • * Patient has had radiation to the current target lesion prior to tissue collection
  • * Patient has multi-centric/multi-focal breast cancer with differing genetic profiles (ER/HER2/PR status differ; if multiple masses are present and not all are tested then exclude patient)
  • * Patient has bilateral breast cancer/Ductal carcinoma in situ (DCIS)
  • * Aim 2 Blood
  • * Cases and Controls:
  • * Patient has known cancer outside of the target cancer 5 years prior to blood collection (not including basal cell or squamous cell skin cancers)
  • * Patient has received chemotherapy class drugs in the 5 years prior to blood collection
  • * Patient has had any prior radiation therapy to the target lesion prior to blood collection
  • * Patient has had a biopsy to the target organ and/or lesion within 3 days before blood collection
  • * Cases:
  • * Patient has had an intervention to completely remove current target pathology
  • * The current target pathology is a recurrence
  • * Patient has multi-centric/multi-focal breast cancer with differing genetic profiles (ER/HER2/PR status differ; if multiple masses are present and not all are tested then exclude patient)
  • * Patient has bilateral breast cancer/DCIS
  • * Aim 3 Urine
  • * Patient has known cancer outside of the target cancer 5 years prior to urine collection (not including basal cell or squamous cell skin cancers)
  • * Patient has received chemotherapy class drugs in the 5 years prior to urine collection
  • * Patient has had any prior radiation therapy to the target lesion prior to urine collection
  • * Patient has had a biopsy to the target organ and/or lesion within 3 days before urine collection
  • * The current target pathology is a recurrence
  • * Patient has chronic indwelling urinary catheter
  • * Patient has had a urinary tract infection within the 14 days prior to sample collection
  • * If patient does not have a primary bladder, ureter or urethral cancer, patient has a history of bladder ureter, or urethral cancer
  • * Cases:
  • * Patient has had an intervention to completely remove current target pathology
  • * The current target pathology is a recurrence
  • * Patient has multi-centric/multi-focal breast cancer with differing genetic profiles \[estrogen receptor (ER)/human epidermal growth factor receptor 2 (HER2)/progesterone receptor (PR)\] status differ; if multiple masses are present and not all are tested then exclude patient)
  • * Patient has bilateral breast cancer/DCIS

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Mayo Clinic,

John B. Kisiel, M.D., PRINCIPAL_INVESTIGATOR, Mayo Clinic in Rochester

Study Record Dates

2028-05-15