Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05338073
Other study ID # KM-20-001
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 12, 2021
Est. completion date January 31, 2026

Study information

Verified date April 2023
Source Known Medicine, Inc.
Contact Charlotte Waits, PhD
Phone 801-953-0895
Email clinical@knownmed.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 2000
Est. completion date January 31, 2026
Est. primary completion date January 31, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Duke Cancer Institute Durham North Carolina
United States MD Anderson Cancer Center Houston Texas
United States Mayo Clinic Rochester Minnesota

Sponsors (4)

Lead Sponsor Collaborator
Known Medicine, Inc. Duke Cancer Institute, M.D. Anderson Cancer Center, Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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.
See also
  Status Clinical Trial Phase
Recruiting NCT05346796 - Survivorship Plan HEalth REcord (SPHERE) Implementation Trial N/A
Recruiting NCT05094804 - A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents Phase 1/Phase 2
Completed NCT04867850 - Effect of Behavioral Nudges on Serious Illness Conversation Documentation N/A
Enrolling by invitation NCT04086251 - Remote Electronic Patient Monitoring in Oncology Patients N/A
Completed NCT01285037 - A Study of LY2801653 in Advanced Cancer Phase 1
Completed NCT00680992 - Study of Denosumab in Subjects With Giant Cell Tumor of Bone Phase 2
Completed NCT00062842 - Study of Irinotecan on a Weekly Schedule in Children Phase 1
Active, not recruiting NCT04548063 - Consent Forms in Cancer Research: Examining the Effect of Length on Readability N/A
Completed NCT04337203 - Shared Healthcare Actions and Reflections Electronic Systems in Survivorship N/A
Recruiting NCT04349293 - Ex-vivo Evaluation of the Reactivity of the Immune Infiltrate of Cancers to Treatments With Monoclonal Antibodies Targeting the Immunomodulatory Pathways N/A
Terminated NCT02866851 - Feasibility Study of Monitoring by Web-application on Cytopenia Related to Chemotherapy N/A
Active, not recruiting NCT05304988 - Development and Validation of the EFT for Adolescents With Cancer
Completed NCT04448041 - CRANE Feasibility Study: Nutritional Intervention for Patients Undergoing Cancer Surgery in Low- and Middle-Income Countries
Completed NCT00340522 - Childhood Cancer and Plexiform Neurofibroma Tissue Microarray for Molecular Target Screening and Clinical Drug Development
Recruiting NCT04843891 - Evaluation of PET Probe [64]Cu-Macrin in Cardiovascular Disease, Cancer and Sarcoidosis. Phase 1
Active, not recruiting NCT03844048 - An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial Phase 3
Completed NCT03109041 - Initial Feasibility Study to Treat Resectable Pancreatic Cancer With a Planar LDR Source Phase 1
Completed NCT03167372 - Pilot Comparison of N-of-1 Trials of Light Therapy N/A
Terminated NCT01441115 - ECI301 and Radiation for Advanced or Metastatic Cancer Phase 1
Recruiting NCT06206785 - Resting Energy Expenditure in Palliative Cancer Patients