RECRUITING

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.

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