ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation

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

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