ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,285
- 试验地点
- 114
- 主要终点
- Distant Recurrence Free Interval (D-RFi)
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 3 years as outlined in the study protocol and informed consent AND
- •Have at least one Landmark blood sample collected. Landmark samples are collected 3-12 weeks after surgery, chemotherapy and/or radiation/chemoradiation as applicable based on the participant's planned treatment regimen
- •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: Cohort 8: Invasive squamous cell carcinoma of the head and neck (includes stage I-IVB HPV-negative or stage III-IVB HPV-positive oral cavity, oropharynx, hypopharynx, larynx, nasopharynx, nasal cavity, or paranasal sinus),
- •Cohort 9: High-risk epithelial ovarian or Fallopian tube carcinoma (defined as FIGO stage IC-III, stage IA-IB that has high grade, carcinosarcoma, or clear cell histology),
- •Cohort 10: Endometrial carcinoma (2023 FIGO Stage II-III or 2023 FIGO Stage IC or any Stage I with p53 abnormal molecular subtype),
- •Cohort 11: High-risk renal cell carcinoma (Defined as high grade (grade 3-4) stage II, stage III or limited stage IV (meaning metastatic sites are considered treatable with curative intent)
- •Cohort 12: Colorectal adenocarcinoma Cohort 12A: 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 OR Cohort 12B: Colon adenocarcinoma (stage II-III)
排除标准
- •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 (defined as cancers confined to the prostate with Gleason score of 7 or lower and prostate-specific antigen (PSA) of less than 20), 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)
研究组 & 干预措施
Cohort 7: Pancreatic adenocarcinoma
That is has been surgically resected or is eligible for surgical resection
干预措施: Guardant Reveal (Diagnostic Test)
Cohort 8: Invasive squamous cell carcinoma of the head and neck
Includes stage I-IVB HPV-negative or stage III-IVB HPV-positive oral cavity, oropharynx, hypopharynx, larynx, nasopharynx, nasal cavity, or paranasal sinus
干预措施: Guardant Reveal (Diagnostic Test)
Cohort 9: High-risk epithelial ovarian or Fallopian tube carcinoma
Defined as FIGO stage IC-III, stage IA-IB that has high grade, carcinosarcoma, or clear cell histology
干预措施: Guardant Reveal (Diagnostic Test)
Cohort 10: Endometrial carcinoma
Defined as 2023 FIGO Stage II-III or 2023 FIGO Stage IC or any Stage I with p53 abnormal molecular subtype
干预措施: Guardant Reveal (Diagnostic Test)
Cohort 11: High-risk renal cell carcinoma
Defined as high grade (grade 3-4) stage II, stage III or limited stage IV (meaning metastatic sites are considered treatable with curative intent).
干预措施: Guardant Reveal (Diagnostic Test)
Cohort 1: Muscle invasive carcinoma of the bladder, ureter, or renal pelvis (stage II-III)
干预措施: Guardant Reveal (Diagnostic Test)
Cohort 2: Non-small cell lung cancer (stage IB-III)
Cohort 2A: Resectable Cohort 2B: Unresectable
干预措施: Guardant Reveal (Diagnostic Test)
Cohort 3: Invasive breast carcinoma with hormone receptor and HER2 status
Cohort 3A: High-risk HER2+ breast cancer (any ER, PR status allowed); defined as having stage II-III or having residual invasive disease (i.e. non-pathologic complete response) following a neoadjuvant chemotherapy-containing regimen OR Cohort 3B: High-risk triple negative breast cancer (TNBC); defined as having stage II-III or having residual invasive disease (i.e. non-pathologic complete response) following a neoadjuvant chemotherapy-containing regimen OR Cohort 3C: HR-positive/HER2-negative invasive breast carcinoma with either >4 positive axillary lymph nodes or 1-3 positive axillary lymph nodes and at least one of the following: tumor size >5 cm, histologic grade 3, or validated gene expression assay indicating high recurrence risk (OncotypeDx score > 26, MammaPrint high, ProSigna high, EndoPredict high)
干预措施: Guardant Reveal (Diagnostic Test)
Cohort 4: Stage IIB-III cutaneous melanoma or limited (resectable) stage IV melanoma
干预措施: Guardant Reveal (Diagnostic Test)
Cohort 5: Esophageal or gastroesophageal junction carcinoma (stage II-III)
干预措施: Guardant Reveal (Diagnostic Test)
Cohort 6: Gastric adenocarcinoma (stage II-III)
干预措施: Guardant Reveal (Diagnostic Test)
Cohort 12: Colorectal adenocarcinoma
12A Rectal Adenocarcinoma: 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 12B Colon Adenocarcinoma: stage II-III
干预措施: Guardant Reveal (Diagnostic Test)
结局指标
主要结局
Distant Recurrence Free Interval (D-RFi)
时间窗: 3 years
The primary endpoint, distant recurrence-free interval (D-RFi), will be evaluated for each of the primary study cohorts. D-RFi is defined as the time from the end of primary treatment until the time of diagnosis of a distant recurrence of the Index Cancer. Subjects without a distant recurrence will be censored at the time of last follow-up of their Index Cancer.
次要结局
- Sensitivity(3 years)
- Positive Predictive Value(3 years)
- Lead Time(3 years)
- Specificity(3 years)
- Negative Predictive Value(3 years)