Purpose

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

Category

IRB Number
20220261HU
NCT Number
-
Open to Enrollment
Yes
Sponsor
-



Study Contact

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



Eligibility

Eligible Ages
18 and above
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Arm Groups