CancerNCT05338073
KM3D Multicenter Cancer Consortium: Predicting Patient Response Using 3D Cell Culture Models
An observational study of Cancer and Predictive Cancer Model, run by Known Medicine, Inc. at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Predictive Cancer Model, Effects of Chemotherapy
- What is being tested?
- Known 3Dx Test
- How many people
- 2,000 participants
- Where
- 3 sitesUnited States
- Study dates
- 12 Jan 2021to 31 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have primary solid cancer that is being surgically resected or biopsied and are 18 years of age or older.
Who may be able to join
- 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
Who cannot join
- Presence of a condition(s) or diagnosis, either physical or psychological, or physical exam finding that precludes participation in the opinion of the Investigator.
Trial locations and contacts
3 sites in 1 country.
Andrea Mazzocchi, PhD contact
United States3 sites, 3 recruiting
- Recruiting
Duke Cancer Institute
Durham, North Carolina, 27710
Kamran Mahmood, MD, k.mahmood@duke.edu
Kamran Mahmood, MD
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
Horiana Grosu, MD, HBGrosu@mdanderson.org
Horiana Grosu, MD
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Janai S Reisenauer, MD, reisenauer.janani@mayo.edu
About this study
Official title: KM3D Multicenter Cancer Consortium Study: Validation of In Vitro 3D Cell Culture Models for Tumor Drug Sensitivity After Tissue Removal
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.
Read the 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.
- Conditions
- Cancer, Predictive Cancer Model, Effects of Chemotherapy
- Being tested
- Known 3Dx Test
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Known 3Dx TestDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Known 3Dx Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2022
- Study start12 Jan 2021
- Primary completion31 Jan 2025 (estimated)
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Known Medicine, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- M.D. Anderson Cancer Center, Duke Cancer Institute, Mayo Clinic
- Responsible party
- Sponsor
- Investigators
- Andrea Mazzocchi, PhD, Principal investigator, Known Medicine, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05338073
- Sponsor's protocol ID
- KM-20-001
- Status last verified
- Apr 2023
- First submitted
- 29 Mar 2022
- Last updated
- 24 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- KM3D Multicenter Cancer Consortium Study: Validation of In Vitro 3D Cell Culture Models for Tumor Drug Sensitivity After Tissue Removal
- ClinicalTrials.gov ID
- NCT05338073
- Acronym / sponsor ID
- KM-20-001
- Conditions
- Cancer, Predictive Cancer Model, Effects of Chemotherapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Known Medicine, Inc.Industry (pharma, biotech, devices)
- Collaborators
- M.D. Anderson Cancer Center, Duke Cancer Institute, Mayo Clinic
- Study start
- 12 Jan 2021 (actual)
- Primary completion
- 31 Jan 2025 (estimated)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 20 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cancer patients | – | Diagnostic Test: Known 3Dx TestPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have primary solid cancer that is being surgically resected or biopsied and are 18 years of age or older.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Presence of a condition(s) or diagnosis, either physical or psychological, or physical exam finding that precludes participation in the opinion of the Investigator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Known 3Dx TestCancer 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 | Diagnostic test | Cancer patients |
Primary outcome
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2023.
- Individual participant dataSharing planned: No
Related trials for Cancer
Not yet recruitingPhase 3
Zopapogene Imadenovec for the Treatment of Recurrent Respiratory Papillomatosis in Children
Recurrent Respiratory Papillomatosis (RRP), Juvenile-onset Recurrent Respiratory Papillomatosis
RecruitingPhase 2
A Clinical Trial Testing the Safety of the Investigational Drug Pumitamig (BNT327) and How Well it Works in Patients With Recurrent Glioblastoma
Recurrent Glioblastoma
Recruiting
MRD Monitoring in Colorectal Cancer Using ctDNA
Colorectal Neoplasms, Colorectal Cancer (Diagnosis)
Recruiting
Implementation of a Pain Management Plan in Major Open Abdominal Surgeries.
Abdomen Cancer, Pancreas Adenocarcinoma (MSI-H)
Recruiting
HEME Home Transfusion Program
Leukemia, Myeloma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Mazzocchi, PhD contact
Andrea Mazzocchi, PhD principal investigator
Known Medicine, Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Predictive Cancer Model, run by Known Medicine, Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Charlotte Waits, PhD (801-953-0895, clinical@knownmed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Drug treatment response (time frame: 7 days after sample receipt). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2023; AzTrials last refreshed its copy on 28 Oct 2026.