Volunteer Login Study Team Login

Print

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
ct.gov registration not required
Open to Enrollment
No

Eligibility

Eligible Ages
-
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

Multi-center, prospective observational study. All ctDNA test results are for research use only and will not be reported for participant care

Study Contact


Regulatory Point of Contact
Frances Crawford
210-450-5037
crawfordf1@uthscsa.edu

Regulatory Point of Contact
Myrna Montenegro
210-450-5954
montenegro@uthscsa.edu

Regulatory Point of Contact
Kathleen Rodriguez
210-450-1365
rodriguezk3@uthscsa.edu

Regulatory Point of Contact
Benjamin Schleif
210-450-1366
schleifb@uthscsa.edu

Regulatory Point of Contact
Morgan Seekatz
210-450-1133
seekatz@uthscsa.edu

Principal Investigator
Sherri Cervantez