This research is being done to see if an investigational blood test can predict whether cancer will recur (come back) after initial treatment
Supreet Kaur
(216) 235-5907
kaurs6@uthscsa.edu
Principal Investigator
Supreet Kaur
Frances Crawford
(210) 450-5037
crawfordf1@uthscsa.edu
Sonia Creighton
(210) 450-1366
creighton@uthscsa.edu
Supreet Kaur
(216) 235-5907
kaurs6@uthscsa.edu
Myrna Montenegro
(210) 450-5954
montenegro@uthscsa.edu
Courtney Nichols
(210) 450-1794
nicholsc2@uthscsa.edu
Mailbox Ctrc Regulatory Affairs
regaffapp@uthscsa.edu
Kathleen Rodriguez
(210) 450-1365
rodriguezk3@uthscsa.edu
Benjamin Schleif
(210) 450-1366
schleifb@uthscsa.edu
Morgan Seekatz
(210) 450-1133
seekatz@uthscsa.edu
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 |
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 |
Multi-center, prospective observational study. All ctDNA test results are for research use only and will not be reported for participant care