Clinical trial NCT05338073: KM3D Multicenter Cancer Consortium: Predicting Patient Response Using 3D Cell Culture Models
Official title: KM3D Multicenter Cancer Consortium Study: Validation of In Vitro 3D Cell Culture Models for Tumor Drug Sensitivity After Tissue Removal
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer
Predictive Cancer Model
Effects of Chemotherapy
Lead sponsor: Known Medicine, Inc.
Sponsor class: INDUSTRY
Collaborators: name: M.D. Anderson Cancer Center
name: Duke Cancer Institute
name: Mayo Clinic
First posted: 2022-04-20
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Drug treatment response
timeFrame: 7 days after sample receipt
measure: Predictive of tumor response
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Durham
country: United States
facility: Duke Cancer Institute
state: North Carolina
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: Known Medicine, Inc.
name: Andrea Mazzocchi, PhD
role: PRINCIPAL_INVESTIGATOR
References: