RecruitingNCT06304168

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

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

Sponsor

Mayo Clinic

Enrollment

6,150 participants

Start Date

May 13, 2019

Study Type

OBSERVATIONAL

Conditions

Hematopoietic and Lymphatic System Neoplasm Malignant Solid Neoplasm

Summary

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

Eligibility

Min Age: 18 Years

Inclusion Criteria17

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

Exclusion Criteria33

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