ORACLE: Observation of ResiduAl Cancer with Liquid biopsy Evaluation
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
- Solid Tumor
- IRB Number
- 20220261HU
- NCT Number
- ct.gov registration not required
- Open to Enrollment
- Yes
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
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
Supreet Kaur
(216) 235-5907
kaurs6@uthscsa.edu
Principal Investigator
Supreet Kaur