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Trial record 1 of 1 for:    NCT05338073
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KM3D Multicenter Cancer Consortium: Predicting Patient Response Using 3D Cell Culture Models

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ClinicalTrials.gov Identifier: NCT05338073
Recruitment Status : Recruiting
First Posted : April 20, 2022
Last Update Posted : January 10, 2023
M.D. Anderson Cancer Center
Duke Cancer Institute
Information provided by (Responsible Party):
Known Medicine, Inc.

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.

Condition or disease Intervention/treatment
Cancer Predictive Cancer Model Effects of Chemotherapy Diagnostic Test: Known 3Dx Test

Detailed Description:

This is a non-interventional clinical study in which (1) cancer tissue that has been resected, biopsied, or drained due to malignant pleural effusion and that is left remaining after (or is not being used during) a pathology investigation and, where possible, (2) a vial of the same patient's blood is sent to Known Medicine Inc. for placement into organoids and subsequent tumor drug sensitivity measurement.

Patients will be consented prior to performance of a medically indicated and pre-planned surgical procedure during which at least a 1cm3 piece of tumor tissue or >100 mL pleural effusion fluid and blood in a separate vial are obtained. These samples will be sent after removal to Known Medicine Inc. from the hospital using a kit provided by Known Medicine. Within the Known Medicine provided kit a data form, freezer pack and containers for the specimens will be provided.

If a solid tissue sample, the tissue will be washed and subsequently digested into a single cell solution using enzymatic digestion methods. Cells will be sorted into cancer and stromal cell populations, stained fluorescently with intramembrane stain, and placed into a 3D cell culture matrix within a multi-well plate. Cells may also be genetically sequenced.

If an aspirated fluid sample, cells will be separated from the fluid and further sorted into cancer cell populations.

Cultures will be allowed to sustain themselves for 48 hours, at which point standard of care chemotherapeutic or other FDA approved drug treatments will be administered. After 72 hours, control and treated wells will be imaged using fluorescence and cell phenotype will be evaluated. Media from cultures may also be evaluated. After imaging, media will be removed and a metabolic assay will be performed to determine culture viability. Using the described quantitative outcomes, tumor sensitivity to each of the administered treatments will be determined.

Patients will be followed and their response to treatment and outcome information from the hospital will be obtained which will allow retrospective validation of tumor organoid sensitivity.

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Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: KM3D Multicenter Cancer Consortium Study: Validation of In Vitro 3D Cell Culture Models for Tumor Drug Sensitivity After Tissue Removal
Actual Study Start Date : January 12, 2021
Estimated Primary Completion Date : January 31, 2025
Estimated Study Completion Date : January 31, 2026

Group/Cohort Intervention/treatment
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
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 Measures :
  1. Drug treatment response [ Time Frame: 7 days after sample receipt ]
    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.

  2. 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. ]
    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.

Biospecimen Retention:   Samples With DNA
cells from solid tissue cancer resections

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05338073

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Contact: Charlotte Waits, PhD 801-953-0895 clinical@knownmed.com
Contact: Andrea Mazzocchi, PhD andrea@knownmed.com

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United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Janai S Reisenauer, MD       reisenauer.janani@mayo.edu   
United States, North Carolina
Duke Cancer Institute Recruiting
Durham, North Carolina, United States, 27710
Contact: Kamran Mahmood, MD       k.mahmood@duke.edu   
Principal Investigator: Kamran Mahmood, MD         
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Horiana Grosu, MD       HBGrosu@mdanderson.org   
Principal Investigator: Horiana Grosu, MD         
Sponsors and Collaborators
Known Medicine, Inc.
M.D. Anderson Cancer Center
Duke Cancer Institute
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Principal Investigator: Andrea Mazzocchi, PhD Known Medicine, Inc.
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Responsible Party: Known Medicine, Inc.
ClinicalTrials.gov Identifier: NCT05338073    
Other Study ID Numbers: KM-20-001
First Posted: April 20, 2022    Key Record Dates
Last Update Posted: January 10, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No