Observing cancer recurrence using a blood test

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The ORACLE study aims to evaluate a novel ctDNA assay developed by Guardant Health for its ability to detect cancer recurrence in patients who have undergone treatment for early-stage solid tumors. Participants will provide blood samples at enrollment and during regular follow-up visits over a period of up to five years. The study will link ctDNA test results to clinical outcomes to establish the assay's clinical validity and explore its potential value in a cost-conscious healthcare environment.

Why it matters

Who can join: the full rules

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)

Where it's running

• University of Alabama at Birmingham
  Birmingham, Alabama, United States Recruiting
• Ironwood Cancer & Research Centers
  Chandler, Arizona, United States Recruiting
• University of California, San Diego
  La Jolla, California, United States Recruiting
• Hoag Memorial Hospital Presbyterian
  Newport Beach, California, United States Recruiting
• Redwood City
  Redwood City, California, United States Recruiting
• University of Colorado
  Aurora, Colorado, United States Recruiting

+7 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Clinical Trial Operations
• Email: mrdoraclestudy@guardanthealth.com
• Phone: 8556988887

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• In-home cancer treatment with remote specialist support for patients in the Florida Panhandle

  This program will try giving standard cancer treatments at home to people living in the Florida Panhandle and nearby areas to see if they prefer it and have better treatment satisfaction.

  Recruiting Phase 2 Mayo Clinic · Jacksonville, Florida · NCT07285044

• Evaluating the safety and effectiveness of ST-067 in treating various solid tumors

  This study is testing a new treatment called ST-067 to see if it can help people with tough-to-treat solid tumors feel better and improve their health.

  Recruiting at 6 sites Phase 1/2 Simcha IL-18, Inc. · Scottsdale, Arizona and 5 other locations · NCT04787042

• XYA02 in advanced solid tumors

  This trial tests XYA02 in adults with MUC1-expressing advanced or relapsed solid tumors to see if it is safe, tolerable, and can shrink tumors.

  Recruiting at 2 sites Phase 1/2 XYone Therapeutics, Inc · Sydney, New South Wales and 4 other locations · NCT07670312

• First-in-human test of HH160 in people with advanced solid tumors

  HH160 is being tested to see if it is safe and how it behaves in the body, to see if it has early signs of helping various advanced cancers in adults.

  Recruiting at 3 sites Phase 1 Huahui Health · Waratah, New South Wales and 2 other locations · NCT07623369

• KRAS G12V cancer patients get TCR1188-ABC cell therapy

  This early-phase trial tests whether TCR1188-ABC cells can safely be given to adults with KRAS G12V-mutated metastatic cancers to see if it can help some types of pancreatic, biliary, colorectal, or lung cancer.

  Recruiting Phase 1 University of Pennsylvania · Philadelphia, Pennsylvania · NCT07594067

• Using the PAGODA algorithm to guide FOLFOX dose changes and reduce unplanned chemotherapy delays

  This trial will test whether using the PAGODA algorithm to guide dose changes during FOLFOX chemotherapy for people with gastrointestinal cancers can reduce unplanned treatment delays.

  Recruiting at 391 sites Alliance for Clinical Trials in Oncology · Fairbanks, Alaska and 397 other locations · NCT07283939

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.