Brief Title
ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation
Official Title
ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation
Brief Summary
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.
Study Type
Observational
Primary Outcome
Distant Recurrence Free Interval (D-RFi)
Secondary Outcome
Sensitivity
Condition
Bladder Carcinoma
Intervention
Guardant Reveal
Study Arms / Comparison Groups
Cohort 1: Muscle invasive carcinoma of the bladder, ureter, or renal pelvis (stage II-III)
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Diagnostic Test
Estimated Enrollment
1000
Start Date
September 7, 2021
Completion Date
October 2027
Primary Completion Date
October 2027
Eligibility Criteria
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) 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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Study Director, 8556988887, [email protected]
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT05059444
Organization ID
02-MX-003
Responsible Party
Sponsor
Study Sponsor
Guardant Health, Inc.
Study Sponsor
Study Director, Study Director, Guardant Health, Inc.
Verification Date
September 2021