RecruitingPhase not listed

ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

ORACLE studies whether a new blood test from Guardant Health can find cancer that comes back after treatment. The test looks for tiny bits of cancer DNA in the blood. The study is for adults treated with the goal of curing certain solid tumors.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are older than 18.
  • Your first cancer treatment is given with the goal of curing the cancer.
  • You plan to have regular visits to check whether the cancer has come back.
  • You sign a consent form agreeing to join the study.
  • You agree to share medical information with researchers after details that identify you are removed.
  • You agree to give blood when you join and at regular follow-up visits for up to 3 years.
  • You have at least one blood sample taken 3–12 weeks after surgery, chemotherapy, radiation, or combined treatment, based on your treatment plan.
  • A tissue test confirms a qualifying cancer of the urinary tract, lung, breast, skin (melanoma), food pipe, stomach, pancreas, head or neck, ovary, fallopian tube, uterus lining, kidney, colon, or rectum. Each group has specific rules about cancer stage, type, risk, or treatment.

Who can't join

  • You have had an organ or tissue transplant from another person.
  • Your cancer is mainly a neuroendocrine cancer, which starts in cells with nerve-like and hormone-making features.
  • You had another new cancer diagnosed within 3 years before joining. Exceptions include cancers that have not grown beyond where they started, non-melanoma skin cancer, certain cancers limited to the prostate, and stage I papillary thyroid cancer. Multiple tumors in the same organ, including paired organs such as the breasts, are also allowed.
  • Your cancer is known to have spread to distant parts of the body when you join. Exceptions apply to limited stage IV skin melanoma that can be removed by surgery and limited stage IV kidney cancer that can be treated with the goal of a cure.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 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) 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 (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)

Study sites (33)

AL

AR

AZ

CA

CO

FL

LA

MA

ME

MI

MN

NC

NJ

NY

OH

PA

SC

TX

UT

WI