Lay Description

This research is being done to see if an investigational blood test can predict whether cancer will recur (come back) after initial treatment


  • Cancers and Other Neoplasms
  • Solid Tumor
IRB Number
NCT Number registration not required
Open to Enrollment


Eligible Ages
18 and above
Eligible Genders
Accepts Healthy Volunteers

Inclusion Criteria

Other Inclusion Criteria:

Age > 18 years old AND

▪ Were treated with curative intent AND

▪ Are planning to undergo regular follow-up and monitoring for cancer recurrence per standard of care at the enrolling site AND

▪ Provided written informed consent to participate in the study AND

▪ Are willing to have de-identified clinical data shared with investigators at regular intervals as outlined in the study protocol and informed consent AND

▪ Are willing to provide blood samples at enrollment and at subsequent clinical visits coinciding with standard of care follow-up, for up to 5 years as outlined in the study protocol and informed consent AND

▪ Have at least one blood sample collected 4-12 weeks after completion of primary treatment of the Index Cancer1

▪ Have a histologically confirmed Index Cancer that qualifies for inclusion, defined as:

Primary Study Cohorts:

▪ Cohort 1: Muscle invasive carcinoma of the bladder, ureter, or renal pelvis (stage II-III)

▪ Cohort 2: Non-small cell lung cancer (stage II-III)

▪ Cohort 3: Invasive breast carcinoma with all of the following:

● Clinical stage T1-4/N0-3/M0 at presentation AND

● Completed preoperative systemic chemotherapy-containing regimen AND

● Underwent definitive surgical resection of the primary tumor AND

● Has pathological evidence of residual invasive carcinoma in the breast and/or axillary lymph nodes AND

● Hormone receptor and HER2 status are known

Exploratory Cohorts:

▪ Cohort 4: Stage IIb-III cutaneous melanoma or limited (resectable) stage IV melanoma treated with curative intent

▪ Cohort 5: Esophageal or gastroesophageal junction carcinoma (stage II-III)

▪ Cohort 6: Gastric adenocarcinoma (stage II-III)

▪ Cohort 7: Surgically resected pancreatic adenocarcinoma

▪ Cohort 8: Invasive squamous cell carcinoma of the head and neck2

▪ Cohort 9: High-risk epithelial ovarian or Fallopian tube carcinoma3

▪ Cohort 10: High-risk endometrial carcinoma4

▪ Cohort 11: High-risk renal cell carcinoma5 

Exclusion Criteria

Other Exclusion Criteria:

History of allogeneic organ or tissue transplant

▪ Index cancer has neuroendocrine histology

▪ History of another primary cancer, with the exception of the following (if adequately treated and the patient is without evidence of disease at the time of enrollment): in situ cancers, non-melanoma skin carcinoma, localized low-risk prostate cancer (Gleason score < 6) with PSA in the normal range, and stage I papillary thyroid carcinoma

▪ Known distant metastasis at time of enrollment (with the exception of participants with limited/resectable stage IV cutaneous melanoma or RCC)

▪ Is participating in a clinical trial or another observational study that is evaluating the performance of another genomic test in the post-treatment surveillance setting at predicting/detecting recurrence

Study Design

Arm Groups

Study Contact

Frances Crawford
(210) 450-5037

Sonia Creighton
(210) 450-1366

Supreet Kaur
(216) 235-5907

Myrna Montenegro
(210) 450-5954

Courtney Nichols
(210) 450-1794

Mailbox Ctrc Regulatory Affairs

Kathleen Rodriguez
(210) 450-1365

Benjamin Schleif
(210) 450-1366

Morgan Seekatz
(210) 450-1133

Supreet Kaur
(216) 235-5907

Principal Investigator
Supreet Kaur