Advanced Cancer3D-PREDICTNCT03561207
3D Prediction of Patient-Specific Response
An observational study of Advanced Cancer and Ovarian Cancer, run by KIYATEC at 9 sites in United States.
Trial summary
This is a prospective, non-randomized, observational registry study evaluating a patient-specific ex vivo 3D (EV3D) assay for drug response using a patient's own biopsy or resected tumor tissue for assessing tissue response to therapy in patients with advanced cancers, including ovarian cancer, high-grade gliomas, and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer, Ovarian Cancer, Glioblastoma Multiforme
- What is being tested?
- EV3D Assay
- How many people
- 570 participants
- Where
- 9 sitesUnited States
- Study dates
- 11 Jun 2018to Dec 2024
- How long will I take part?
- 2 Years
- 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 with suspected, newly diagnosed or relapsed diagnosis of advanced cancer (ovarian, brain, or other rare tumors) undergoing surgery or biopsy to remove tumor tissue will be enrolled and their tissue collected and tested with the EV3D Assay across drugs that are most often used to treat the specified cancer types, including standard of care therapies or as recommended by NCCN guidelines.
Who may be able to join
- Age 18 years and older
- Diagnosis of or suspected diagnosis of EOC, HGG, high-grade RT
- Individual must undergo elective surgery or biopsy to remove tumor tissue
- Consideration as a candidate for systemic therapy with cytotoxic chemotherapy, targeted small molecule inhibitors or immunotherapy
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 3
- Written informed consent in accordance with institutional standards must be obtained from the patient or legal guardian
Who cannot join
- Inability or refusal of the patient or legal guardian to sign a written informed consent
- Failure to have surgery or a biopsy as part of routine clinical practice
- Refusal to have the Assay performed on their tissue
- Known active cancer metastatic to the brain except for patients with brain metastases that have been treated and are considered stable.
- Inability or unwillingness to receive chemotherapy treatment beyond surgery
- Any coincidental medical condition that, in the Investigator's opinion, would preclude participation in the study or compromise the patient's ability to give informed consent
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Roswell Park Cancer Institute
Buffalo, New York, 14203
Inova Fairfax Hospital
Falls Church, Virginia, 22042
Prisma Health
Greenville, South Carolina, 29605
Penn State Health, Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
University of Arkansas for Medical Sciences, Winthrop P. Rockefeller Cancer Institute
Little Rock, Arkansas, 72205-7199
Oregon Health & Science University
Portland, Oregon, 97239
Veterans Administration Portland Health Care System
Portland, Oregon, 97239
University of California, San Francisco
San Francisco, California, 94143
Capital Health Institute for Neurosciences
Trenton, New Jersey, 08638
About this study
Official title: 3D-PREDICT REGISTRY: 3D Prediction of Patient-specific Response Using Ex Vivo Interrogation of Live Cells From Tumors
This is a prospective, non-randomized, observational registry study evaluating a patient-specific ex vivo 3D (EV3D) assay for drug response using a patient's own biopsy or resected tumor tissue for assessing tissue response to therapy in patients with advanced cancers, including ovarian cancer, high-grade gliomas, and high-grade rare tumors.
Read the detailed description
This protocol defines a prospective, open-label, multi-institutional, non-interventional study for the purpose of examining the Assay's clinical use and potential to impact patient outcomes. This Study will establish a registry of clinical parameters, including clinical response, clinical outcomes, Assay performance and potential utilization across multiple types of advanced cancers in consenting patients who have their tumor tissue tested by the Assay. Physicians may have access to Assay results which which predict therapeutic response to cancer drugs most often prescribed to treat the specified indications. For cancers with standard of care (SOC) cancer drug treatments, the Assay panel tests SOC systemic agents per NCCN guidelines, some of which may include both FDA approved and off-label FDA approved therapies. The Assay currently assesses the most common cancer drugs across multiple tumor types. It requires freshly obtained tumor specimen that has not been previously preserved for traditional histologic analysis. The Registry will focus initially on tumor types and agents which have been analytically validated with the Assay and determined to meet strict laboratory qualifications and standards. The Registry will collect data on a limited number of cancer types to include epithelial ovarian cancer (EOC), high-grade gliomas (HGG) limited to anaplastic astrocytoma (AA) and glioblastoma multiforme (GBM), and high-grade rare tumors (RT).
- Being tested
- EV3D Assay
- Medical subject headings
- Ovarian Neoplasms, Glioblastoma, Astrocytoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EV3D AssayDiagnostic test
The EV3D assay uses freshly obtained tumor specimen to predict tissue drug response.
| Study group | Role | What they receive |
|---|---|---|
| Tumor tissue tested with EV3D Assay | Cancer tissue from multiple sites in the body, to include ovarian, brain, and other rare tumors. Receives: Diagnostic Test: EV3D Assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
Establish correlation of Assay results with patient outcomes
Compare Assay results to reported patient outcomes
Measured: 2 year
Secondary outcomes (5)
Evaluate the use of Assay results and the effects on medical decision-making and patient outcomes
Determine potential effect of Assay results on treatment plan
Measured: 2 year
Compare clinical response (progression free survival or time to progression) in patients who receive treatment aligned with Assay results of response versus patients who are not treated aligned with Assay results of response
Compare Assay results to study patient clinical response
Measured: 2 years
Compare clinical response (progression free survival or time to progression) in patients who receive treatment aligned with Assay results of response versus historical response rates
Compare Assay results to historical clinical response rates
Measured: 2 years
Compare clinical outcomes (event free survival and overall survival) in patients who are treated aligned with Assay results versus historical response rates
Compare survival of study patients aligned with Assay results to historical survival rates
Measured: 2 years
Define Assay success across histologic subtypes and classes of anti-cancer compounds
Evaluate Assay success rate
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2018
- Study start11 Jun 2018
- Primary completionJun 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Advanced 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 570 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- KIYATEC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03561207
- Sponsor's protocol ID
- KIY-REG-001
- Acronym
- 3D-PREDICT
- Status last verified
- Mar 2023
- First submitted
- 10 Jun 2018
- Last updated
- 24 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shuford S, Wilhelm C, Rayner M, Elrod A, Millard M, Mattingly C, Lotstein A, Smith AM, Guo QJ, O'Donnell L, Elder J, Puls L, Weroha SJ, Hou X, Zanfagnin V, Nick A, Stany MP, Maxwell GL, Conrads T, Sood AK, Orr D, Holmes LM, Gevaert M, Crosswell HE, DesRochers TM. Prospective Validation of an Ex Vivo, Patient-Derived 3D Spheroid Model for Response Predictions in Newly Diagnosed Ovarian Cancer. Sci Rep. 2019 Aug 1;9(1):11153. doi: 10.1038/s41598-019-47578-7.
PubMed 31371750Shuford S, Lipinski L, Abad A, Smith AM, Rayner M, O'Donnell L, Stuart J, Mechtler LL, Fabiano AJ, Edenfield J, Kanos C, Gardner S, Hodge P, Lynn M, Butowski NA, Han SJ, Redjal N, Crosswell HE, Vibat CRT, Holmes L, Gevaert M, Fenstermaker RA, DesRochers TM. Prospective prediction of clinical drug response in high-grade gliomas using an ex vivo 3D cell culture assay. Neurooncol Adv. 2021 May 7;3(1):vdab065. doi: 10.1093/noajnl/vdab065. eCollection 2021 Jan-Dec.
PubMed 34142085Reed MR, Lyle AG, De Loose A, Maddukuri L, Learned K, Beale HC, Kephart ET, Cheney A, van den Bout A, Lee MP, Hundley KN, Smith AM, DesRochers TM, Vibat CRT, Gokden M, Salama S, Wardell CP, Eoff RL, Vaske OM, Rodriguez A. A Functional Precision Medicine Pipeline Combines Comparative Transcriptomics and Tumor Organoid Modeling to Identify Bespoke Treatment Strategies for Glioblastoma. Cells. 2021 Dec 2;10(12):3400. doi: 10.3390/cells10123400.
PubMed 34943910
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3D-PREDICT REGISTRY: 3D Prediction of Patient-specific Response Using Ex Vivo Interrogation of Live Cells From Tumors
- ClinicalTrials.gov ID
- NCT03561207
- Acronym / sponsor ID
- 3D-PREDICT / KIY-REG-001
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 570 participants (estimated)
- Lead sponsor
- KIYATECIndustry (pharma, biotech, devices)
- Study start
- 11 Jun 2018 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 19 Jun 2018 (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 is a prospective, non-randomized, observational registry study evaluating a patient-specific ex vivo 3D (EV3D) assay for drug response using a patient's own biopsy or resected tumor tissue for assessing tissue response to therapy in patients with advanced cancers, including ovarian cancer, high-grade gliomas, and high-grade rare tumors.
Detailed description
This protocol defines a prospective, open-label, multi-institutional, non-interventional study for the purpose of examining the Assay's clinical use and potential to impact patient outcomes. This Study will establish a registry of clinical parameters, including clinical response, clinical outcomes, Assay performance and potential utilization across multiple types of advanced cancers in consenting patients who have their tumor tissue tested by the Assay. Physicians may have access to Assay results which which predict therapeutic response to cancer drugs most often prescribed to treat the specified indications. For cancers with standard of care (SOC) cancer drug treatments, the Assay panel tests SOC systemic agents per NCCN guidelines, some of which may include both FDA approved and off-label FDA approved therapies. The Assay currently assesses the most common cancer drugs across multiple tumor types. It requires freshly obtained tumor specimen that has not been previously preserved for traditional histologic analysis. The Registry will focus initially on tumor types and agents which have been analytically validated with the Assay and determined to meet strict laboratory qualifications and standards. The Registry will collect data on a limited number of cancer types to include epithelial ovarian cancer (EOC), high-grade gliomas (HGG) limited to anaplastic astrocytoma (AA) and glioblastoma multiforme (GBM), and high-grade rare tumors (RT).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tumor tissue tested with EV3D Assay | – | Diagnostic Test: EV3D AssayCancer tissue from multiple sites in the body, to include ovarian, brain, and other rare tumors. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with suspected, newly diagnosed or relapsed diagnosis of advanced cancer (ovarian, brain, or other rare tumors) undergoing surgery or biopsy to remove tumor tissue will be enrolled and their tissue collected and tested with the EV3D Assay across drugs that are most often used to treat the specified cancer types, including standard of care therapies or as recommended by NCCN guidelines.
Key inclusion criteria (6 listed)
- Age 18 years and older
- Diagnosis of or suspected diagnosis of EOC, HGG, high-grade RT
- Individual must undergo elective surgery or biopsy to remove tumor tissue
- Consideration as a candidate for systemic therapy with cytotoxic chemotherapy, targeted small molecule inhibitors or immunotherapy
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 3
Key exclusion criteria (6 listed)
- Inability or refusal of the patient or legal guardian to sign a written informed consent
- Failure to have surgery or a biopsy as part of routine clinical practice
- Refusal to have the Assay performed on their tissue
- Known active cancer metastatic to the brain except for patients with brain metastases that have been treated and are considered stable.
- Inability or unwillingness to receive chemotherapy treatment beyond surgery
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 |
|---|---|---|
| EV3D AssayThe EV3D assay uses freshly obtained tumor specimen to predict tissue drug response. | Diagnostic test | Tumor tissue tested with EV3D Assay |
Primary outcome
Establish correlation of Assay results with patient outcomes
Time frame: 2 year
Compare Assay results to reported patient outcomes
5 secondary outcomes
Evaluate the use of Assay results and the effects on medical decision-making and patient outcomes
Time frame: 2 year
Compare clinical response (progression free survival or time to progression) in patients who receive treatment aligned with Assay results of response versus patients who are not treated aligned with Assay results of response
Time frame: 2 years
Compare clinical response (progression free survival or time to progression) in patients who receive treatment aligned with Assay results of response versus historical response rates
Time frame: 2 years
Compare clinical outcomes (event free survival and overall survival) in patients who are treated aligned with Assay results versus historical response rates
Time frame: 2 years
Define Assay success across histologic subtypes and classes of anti-cancer compounds
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2023.
- Background: PubMed 31371750Shuford S, Wilhelm C, Rayner M, Elrod A, Millard M, Mattingly C, Lotstein A, Smith AM, Guo QJ, O'Donnell L, Elder J, Puls L, Weroha SJ, Hou X, Zanfagnin V, Nick A, Stany MP, Maxwell GL, Conrads T, Sood AK, Orr D, Holmes LM, Gevaert M, Crosswell HE, DesRochers TM. Prospective Validation of an Ex Vivo, Patient-Derived 3D Spheroid Model for Response Predictions in Newly Diagnosed Ovarian Cancer. Sci Rep. 2019 Aug 1;9(1):11153. doi: 10.1038/s41598-019-47578-7.
- Results publication: PubMed 34142085Shuford S, Lipinski L, Abad A, Smith AM, Rayner M, O'Donnell L, Stuart J, Mechtler LL, Fabiano AJ, Edenfield J, Kanos C, Gardner S, Hodge P, Lynn M, Butowski NA, Han SJ, Redjal N, Crosswell HE, Vibat CRT, Holmes L, Gevaert M, Fenstermaker RA, DesRochers TM. Prospective prediction of clinical drug response in high-grade gliomas using an ex vivo 3D cell culture assay. Neurooncol Adv. 2021 May 7;3(1):vdab065. doi: 10.1093/noajnl/vdab065. eCollection 2021 Jan-Dec.
- Results publication: PubMed 34943910Reed MR, Lyle AG, De Loose A, Maddukuri L, Learned K, Beale HC, Kephart ET, Cheney A, van den Bout A, Lee MP, Hundley KN, Smith AM, DesRochers TM, Vibat CRT, Gokden M, Salama S, Wardell CP, Eoff RL, Vaske OM, Rodriguez A. A Functional Precision Medicine Pipeline Combines Comparative Transcriptomics and Tumor Organoid Modeling to Identify Bespoke Treatment Strategies for Glioblastoma. Cells. 2021 Dec 2;10(12):3400. doi: 10.3390/cells10123400.
- Prospective Validation of an Ex Vivo, Patient-Derived 3D Spheroid Model for Response Predictions in Newly Diagnosed Ovarian CancerLink provided by the sponsor.
- Prospective prediction of clinical drug response in high-grade gliomas using an ex vivo 3D cell culture assayLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Advanced Cancer and Ovarian Cancer, run by KIYATEC at 9 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 6 inclusion and 6 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 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Establish correlation of Assay results with patient outcomes (time frame: 2 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03561207, which also lists 3 linked publications.
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 Mar 2023; AzTrials last refreshed its copy on 6 Nov 2026.