ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation (ORACLE)
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 21-011604
NCT ID: NCT05059444
Sponsor Protocol Number: 02-MX-003
About this study
The purpose of ORACLE is to demonstrate the ability of a novel ctDNA assay developed by Guardant Health to detect recurrence in individuals treated for early-stage solid tumors. It is necessary that ctDNA test results are linked to clinical outcomes in order to demonstrate clinical validity for recurrence detection and explore its value in a healthcare environment subject to cost containment.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
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 Cancer.
- 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 neck (includes stage I-III oral cavity, oropharynx, hypopharynx, larynx, nasopharynx, nasal cavity, paranasal sinus, and salivary gland cancers).
- Cohort 9: High-risk epithelial ovarian or Fallopian tube carcinoma (defined as stage IC-III or stage I that has high grade (grade 3-4) or clear cell histology).
- Cohort 10: High-risk endometrial carcinoma (defined as having any of the following: serous or clear cell adenocarcinoma histology (any stage), grade 3 or 4 deeply invasive (T1b or greater) endometrioid carcinoma, stage III disease (any histology)).
- Cohort 11: High-risk renal cell carcinoma (defined as high grade (grade 3-4) stage II, stage III or limited (resectable) stage IV treated with curative intent).
- For the purposes of this study, participants receiving extended (> 6 months planned duration) non-chemotherapy systemic treatment will be considered in their end of primary treatment phase after the initial planned surgery, chemotherapy and/or radiation.
- Determination of stage for eligibility assessment and enrollment should be based on pathologic stage unless the participant received pre-surgical/neoadjuvant therapy, in which case standard pre-treatment clinical staging will be used to determine eligibility.
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.
Eligibility last updated 11/3/21. Questions regarding updates should be directed to the study team contact.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
More information
Publications
Publications are currently not available