ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation

Launched by GUARDANT HEALTH, INC. · Sep 17, 2021

Keywords

ClinConnect Summary

The ORACLE trial is investigating a new blood test developed by Guardant Health that looks for small pieces of cancer DNA in the blood, known as ctDNA, in patients who have been treated for early-stage solid tumors. The goal is to see if this test can help detect if the cancer returns after treatment. This study is important because it could provide valuable information about the effectiveness of the ctDNA test in monitoring cancer recurrence, which is crucial for improving patient care.

To be eligible for the trial, participants must be adults over 18 who have been treated for specific types of cancer with the intent to cure and who are planning to follow standard check-ups for cancer monitoring. Participants will need to provide blood samples at various times, including shortly after their initial treatment and during follow-up visits over the next five years. If you or a loved one are interested, it’s essential to discuss this opportunity with your healthcare provider to see if it’s a good fit.

Gender

ALL

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 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 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
• • 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: 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 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),
• • 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)
• • 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