ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation
Recruiting
Observational Study
Bladder CarcinomaUreter CarcinomaRenal Pelvis CarcinomaNon-small Cell Lung CancerInvasive Breast CarcinomaCutaneous MelanomaEsophageal CarcinomaGastroesophageal Junction CarcinomaGastric AdenocarcinomaPancreatic AdenocarcinomaSquamous Cell Carcinoma of the Head and NeckEpithelial Ovarian CarcinomaFallopian Tube CarcinomaEndometrial CarcinomaRenal Cell CarcinomaRectal Adenocarcinoma
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Observational
Participants needed
2,020 (estimated)
Sponsor
Guardant Health, Inc. · Industry
Who this trial is looking for
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Age \> 18 years old AND
* Initial treatment is given with curative/radical 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…
Inclusion Criteria:
* Age \> 18 years old AND
* Initial treatment is given with curative/radical 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 Landmark blood sample
Have a histologically confirmed Index Cancer that qualifies for inclusion, defined as:
Primary Study Cohorts
* Cohort 1: Cohort 1: Muscle invasive carcinoma of the bladder, ureter, or renal pelvis (stage II-III),
* Cohort 2: Cohort 2: Non-small cell lung cancer (stage IB-III):
Cohort 2A: Resectable OR Cohort 2B: Unresectable,
* Cohort 3: Invasive breast carcinoma with hormone receptor (e.g. estrogen receptor (ER) and progesterone receptor (PR) expression) and human epidermal growth factor receptor 2 (HER2) status known and one the following:
Cohort 3A: High-risk2 HER2+ breast cancer (any ER, PR status allowed) OR Cohort 3B: High-risk2 triple negative breast cancer (TNBC) OR Cohort 3C: High-risk3 HR-positive/HER2-negative invasive breast carcinoma,
* 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: Pancreatic adenocarcinoma that is has been surgically resected or is eligible for surgical resection,
* Cohort 8: Invasive squamous cell carcinoma of the head and neck (Includes stage I-IVB oral cavity, oropharynx, hypopharynx, larynx, nasopharynx, nasal cavity, and paranasal sinus cancers),
* Cohort 9: High-risk epithelial ovarian or Fallopian tube carcinoma (Defined as FIGO stage IC-III or stage IA-IB that has high grade or clear cell histology),
* Cohort 10: High-risk endometrial carcinoma (Defined as 2023 FIGO Stage II-III),
* 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)
Exploratory Cohort
* Cohort 12: Pathologically confirmed adenocarcinoma of the rectum (located up to 15 cm from the anal verge) that is undergoing or underwent a preoperative chemotherapy- or immunotherapy- containing regimen
Exclusion Criteria:
* History of allogeneic organ or tissue transplant
* Index cancer has predominantly neuroendocrine histology
* History of another primary cancer diagnosed within 3 years of enrollment, with the exception that in situ cancers, non-melanoma skin carcinomas, localized low- or intermediate risk prostate cancers, and stage I papillary thyroid carcinoma, and participants with bilateral/multifocal tumors within the same organ (for example, bilateral breast cancer) are allowed if diagnosed within 3 years of enrollment
* Known distant metastasis at time of enrollment (with the exception of participants with limited/resectable stage IV cutaneous melanoma or RCC)
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