KM3D Multicenter Cancer Consortium: Predicting Patient Response Using 3D Cell Culture Models

NCT05338073 | Unknown FDA Device

• 1 other identifier: KM-20-001
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 3

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

Outcome Measures

Primary Outcomes (2)

• Drug treatment response

  Measurements of changes in cell population size and phenotype will be taken from cellular imaging done before and during compound or drug administration. Platform drug response is defined as a statistically significant difference between drug-treated micro-tumors grown from the patient's sample and untreated control wells.

  7 days after sample receipt

• Predictive of tumor response

  To understand if cellular phenotypic and population changes seen in Outcome 1 are clinically relevant we will compare the statistically significant changes we see to actual patient response on that treatment. The goal is to grow a large enough data set to gain an understanding about which of the changes seen by the KM3D test are clinically relevant.

  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.

Study Arms (1)

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.

Diagnostic Test: Known 3Dx Test

Interventions

Known 3Dx Test DIAGNOSTIC_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

Cancer patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who have primary solid cancer that is being surgically resected or biopsied and are 18 years of age or older.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Known Medicine, Inc.: lead
• M.D. Anderson Cancer Center: collaborator
• Duke Cancer Institute: collaborator
• Mayo Clinic: collaborator

Study Sites (3)

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

Duke Cancer Institute

Durham, North Carolina, 27710, United States

RECRUITING

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

cells from solid tissue cancer resections

MeSH Terms

Conditions

Neoplasms

Study Officials

• Andrea Mazzocchi, PhD

  Known Medicine, Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Charlotte Waits, PhD

CONTACT

801-953-0895; clinical@knownmed.com

Andrea Mazzocchi, PhD

CONTACT

andrea@knownmed.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2022
• First Posted: April 20, 2022
• Study Start: January 12, 2021
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2026
• Last Updated: April 24, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)