Clinical Trials

ORACLE: Observation of ResiduAl Cancer with Liquid biopsy Evaluation (CTMS# 22-0052)

Cancer Type

Solid Tumor

ClinicalTrials.gov Identifier

ClinicalTrials.gov registration not required

Principal Investigator

Supreet Kaur M.D.

For more information about this study
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About This Study

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

What is the criteria to participate?

Note: This is only a partial list of eligibility criteria.

Inclusion Criteria:
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:
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