Recruiting

Observational Study

Sponsor:

Known Medicine, Inc.

Code:

NCT05338073

Conditions

Cancer

Predictive Cancer Model

Effects of Chemotherapy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Known 3Dx Test

Study Details

Brief summary:

This study will assess the ability of the Known Medicine platform to predict the efficacy of certain cancer drug treatments and to validate that tumor organoid drug sensitivity is representative of patient treatment outcomes.

Conditions

Cancer

Predictive Cancer Model

Effects of Chemotherapy

Study ID

NCT05338073

Start date

Jan 12, 2021

Status verified date

Apr, 2023

Completion date

Jan 31, 2026

Anticipated

Primary completion date

Jan 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • A demonstrated primary solid cancer for which it is medically indicated and planned to be surgically resected, biopsied, or drained (via malignant pleural effusion).
  • The ability to ship the tissue sample within 24 hours of removal from the patient.
  • Signed and dated consent to giving tissue as well as allowing for de-identified medical history information regarding administered treatments and treatment outcomes to be shared.
  • over 18 years of age

Exclusion Criteria:

  • Presence of a condition(s) or diagnosis, either physical or psychological, or physical exam finding that precludes participation in the opinion of the Investigator.

Study Design

Enrollment

2000 participants

Anticipated

Interventions and Outcome Measures

Arms

Cancer patients

Patients who have primary solid cancer that is being surgically resected, biopsied, or drained (via malignant pleural effusion) and are 18 years of age or older.

Interventions

Known 3Dx Test

Cancer tissue is cultured and treated with a panel of FDA approved chemotherapy and targeted therapies at a range of doses. Cell growth and phenotypes are measured to determine which treatment or treatment combinations would yield the best results for a patient. Test results are compared to actual patient outcomes collected at 3, 6, 9, and 12 months post tissue collection to determine the predictive power of the Known 3Dx Test

Primary outcome measure

  • Drug treatment response [ Time Frame: 7 days after sample receipt ]
  • Predictive of tumor response [ Time Frame: 3 to 12 months post tissue collection (depending on when the physician prescribed treatment course is complete). Treatment updates will be given at 3, 6, 9, and 12 months but only the final reported result will be used for comparison. ]

Central Contacts and Locations

Central contacts

Charlotte Waits, PhD

801-953-0895clinical@knownmed.com

Andrea Mazzocchi, PhD

andrea@knownmed.com

Locations

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Janai S Reisenauer, MD

reisenauer.janani@mayo.edu

Duke Cancer Institute

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Kamran Mahmood, MD

k.mahmood@duke.edu

Principal Investigator:

Kamran Mahmood, MD

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Horiana Grosu, MD

HBGrosu@mdanderson.org

Principal Investigator:

Horiana Grosu, MD

More Information

Sponsor

Known Medicine, Inc.

Last update posted

Apr 24, 2023

Last verified

Apr, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Known Medicine, Inc. on 2023-04-24.