Ensayos clínicos

Inclusion Criteria - Aim 1 Tissue:

• Adults, age >18 years old.

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.

Exclusion Criteria - Aim 1 Tissue:

• Individuals under 18 years of age.

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/DCIS.

Inclusion Criteria - 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.

Exclusion Criteria - 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 had any transplants 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.

Inclusion Criteria: 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 Criteria: 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 (ER/HER2/PR status differ; if multiple masses are present and not all are tested then exclude patient).
•  Patient has bilateral breast cancer/DCIS.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 6/16/23. Questions regarding updates should be directed to the study team contact.