RECRUITING

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

Conditions

Hematopoietic and Lymphatic System Neoplasm Malignant Solid Neoplasm

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2019-05-13

Study Completion:2028-05-15

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06304168

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Principal Investigator

John B. Kisiel, M.D.

PRINCIPAL_INVESTIGATOR

Mayo Clinic in Rochester

Study Locations (Sites)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905

United States

Collaborators and Investigators

Sponsor: Mayo Clinic

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-05-13

Study Completion Date2028-05-15

Study Record Updates

Study Start Date2019-05-13

Study Completion Date2028-05-15

Terms related to this study

Additional Relevant MeSH Terms

Hematopoietic and Lymphatic System Neoplasm
Malignant Solid Neoplasm