RECRUITING

ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation

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Conditions

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 Carcinoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation

Quick Facts

Study Start:2021-09-07
Study Completion:2028-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05059444

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age \> 18 years old AND
  2. * Were treated with curative intent AND
  3. * Are planning to undergo regular follow-up and monitoring for cancer recurrence per standard of care at the enrolling site AND
  4. * Provided written informed consent to participate in the study AND
  5. * Are willing to have de-identified clinical data shared with investigators at regular intervals as outlined in the study protocol and informed consent AND
  6. * 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
  7. * Have at least one blood sample collected 4-12 weeks after completion of primary treatment of the Index Cancer
  8. * Have a histologically confirmed Index Cancer that qualifies for inclusion, defined as:
  9. * Cohort 1: Muscle invasive carcinoma of the bladder, ureter, or renal pelvis (stage II-III),
  10. * Cohort 2: Non-small cell lung cancer (stage II-III),
  11. * Cohort 3: Invasive breast carcinoma with all of the following:
  12. * Cohort 4: Stage IIb-III cutaneous melanoma or limited (resectable) stage IV melanoma treated with curative intent,
  13. * Cohort 5: Esophageal or gastroesophageal junction carcinoma (stage II-III),
  14. * Cohort 6: Gastric adenocarcinoma (stage II-III),
  15. * Cohort 7: Surgically resected pancreatic adenocarcinoma,
  16. * Cohort 8: Invasive squamous cell carcinoma of the head and neck (includes stage I-III oral cavity, oropharynx, hypopharynx, larynx, nasopharynx, nasal cavity, paranasal sinus, and salivary gland cancers),
  17. * 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),
  18. * 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)),
  19. * 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)
  1. * History of allogeneic organ or tissue transplant
  2. * Index cancer has neuroendocrine histology
  3. * History of another primary cancer, with the exception of the following (if adequately treated and the patient is without evidence of disease at the time of enrollment): in situ cancers, non-melanoma skin carcinoma, localized low-risk prostate cancer (Gleason score \< 6) with PSA in the normal range, and stage I papillary thyroid carcinoma.
  4. * Known distant metastasis at time of enrollment (with the exception of participants with limited/resectable stage IV cutaneous melanoma or RCC)
  5. * 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

Contacts and Locations

Study Contact

Clinical Trial Operations
CONTACT
8556988887
mrdoraclestudy@guardanthealth.com

Principal Investigator

Study Director
STUDY_DIRECTOR
Guardant Health, Inc.

Study Locations (Sites)

Redwood City
Redwood City, California, 94063
United States

Collaborators and Investigators

Sponsor: Guardant Health, Inc.

  • Study Director, STUDY_DIRECTOR, Guardant Health, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-09-07
Study Completion Date2028-02

Study Record Updates

Study Start Date2021-09-07
Study Completion Date2028-02

Terms related to this study

Additional Relevant MeSH Terms

  • Bladder Carcinoma
  • Ureter Carcinoma
  • Renal Pelvis Carcinoma
  • Non-small Cell Lung Cancer
  • Invasive Breast Carcinoma
  • Cutaneous Melanoma
  • Esophageal Carcinoma
  • Gastroesophageal Junction Carcinoma
  • Gastric Adenocarcinoma
  • Pancreatic Adenocarcinoma
  • Squamous Cell Carcinoma of the Head and Neck
  • Epithelial Ovarian Carcinoma
  • Fallopian Tube Carcinoma
  • Endometrial Carcinoma
  • Renal Cell Carcinoma