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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

Category

  • Cancers and Other Neoplasms
  • Wounds and Injuries
  • Solid Tumor
IRB Number
20220261HU
NCT Number
NCT # not yet entered

Eligibility

Eligible Ages
18 and above
Eligible Genders
All
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
crawfordf1@uthscsa.edu

Myrna Montenegro
210-450-5954
montenegro@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

Principal Investigator
Supreet Kaur