ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation

  • STATUS
    Recruiting
  • End date
    Oct 4, 2027
  • participants needed
    1000
  • sponsor
    Guardant Health, Inc.
Updated on 4 October 2021
cancer
carcinoma
squamous cell carcinoma
lung cancer
cavity
gastric adenocarcinoma
pancreatic adenocarcinoma
HER2
primary tumor
cancer chemotherapy
adenocarcinoma
erbb2
liquid biopsy
fallopian tube
cancer recurrence
endometrioid adenocarcinoma
endometrial carcinoma
clear cell adenocarcinoma
endometrioid carcinoma
lung carcinoma
malignant melanoma of skin

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.

Details
Condition Non-Small Cell Lung Cancer, Adenocarcinoma, Endometrial Carcinoma, Malignant neoplasm of kidney, Uterine Cancer, bladder cancer, Fallopian Tube Cancer, melanoma, Renal Cell Carcinoma, Pancreatic Adenocarcinoma, Esophageal Carcinoma, Invasive Breast Carcinoma, Gastric Adenocarcinoma, Squamous Cell Carcinoma of the Head and Neck, Invasive Breast Cancer, Squamous Cell Carcinoma of Head and Neck, Epithelial Ovarian Carcinoma, Ureter Carcinoma, Renal Pelvis Carcinoma, Renal Cell Cancer, Bladder Carcinoma, clear cell renal cell carcinoma, fallopian tube carcinoma, melanoma skin, melanoma skin cancer, malignant melanoma of skin, ovarian epithelial carcinoma, carcinoma of the ovary, carcinoma of the bladder, nsclc, fallopian tube cancers, stomach adenocarcinoma, cancer of the esophagus, oesophageal carcinoma, Gastroesophageal Junction Carcinoma
Treatment Guardant Reveal
Clinical Study IdentifierNCT05059444
SponsorGuardant Health, Inc.
Last Modified on4 October 2021

Eligibility

Yes No Not Sure

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
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