Non-Small Cell Lung CancerNCT02577627
Multi-Indication, Retrospective Oncological Study to Validate the Accuracy in Predicting TTP by PrediCare in Patients Under SOC
An observational study of Non-Small Cell Lung Cancer and Small Cell Lung Cancer, run by Optimata Ltd. at 1 site in Israel.
Trial summary
This is a retrospective observational, open label study to evaluate and prospectively validate in a blind manner the accuracy of predicting treatment outcomes by PrediCare in individual patients with Non-Small Cell Lung Cancer, Small Cell Lung Cancer, Castration-Resistant Prostate Cancer, Breast Cancer \& Colon Cancer… Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Non-Small Cell Lung Cancer, Small Cell Lung Cancer, Prostate Cancer
- What is being tested?
- PrediCare
- Type of treatment
- Medical device
- How many people
- 5,000 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2015to Sep 2019
- 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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Data from up to about 1000 NSCLC patients' files will be collected. Data from up to about 1000 SCLC patients' files will be collected. Data from up to about 1000 Colon cancer patients' files will be collected. Data from up to about 1000 Breast cancer patients' files will be collected. Data from up to about 1000 Prostate cancer patients' files will be collected.
Who may be able to join
- Lung Cancer (NSCLC):
- Gender: Female, Male.
- Age: Eighteen years and older at the start of treatment.
- Stage: Pathologically or cytologically determined advanced or locally advanced NSCLC at Stage III/IV, adenocarcinoma, OR Pathologically or cytologically determined advanced or locally advanced NSCLC at Stage III/IV, NOS.
- Lung cancer with measurable disease at the start of treatment.
- No prior chemotherapy unless used in adjuvant therapy, completed more than 12 month before.
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- Patient has at least one quantitative measurements of at least one lesion in lung (primary tumor or metastasis) before treatment.
- Patient has at least one quantitative measurements of at least one lesion in lung (primary tumor or metastasis) during or after the treatment.
- Patient has at least one recorded visit to the treating oncologist before treatment.
- Patient has at least one recorded visit to the treating oncologist during or after the treatment.
- Treatment as per SOC for NSCLC.
- Lung Cancer (SCLC):
- Genders Eligible for Study: Female/Male patient.
- Ages between 18 and older at the start of treatment.
- Pathologically or cytologically determined advanced or locally advanced SCLC at Stage III/IV.
- Lung cancer with measurable disease at the start of treatment.
- No prior chemotherapy unless used in adjuvant therapy, completed more than 12 month ago.
- Patient has at least one quantitative measurements of at least one lesion in lung (primary tumor or metastasis) before treatment.
- Patient has at least one quantitative measurements of at least one lesion (primary tumor or metastasis) during or after the treatment.
- Patient has at least one recorded visit to the treating oncologist before treatment.
- Patient has at least one recorded visit to the treating oncologist during or after the treatment.
- Treatment as per SOC for SCLC.
- Colon Cancer:
- Genders Eligible for Study: Female/Male patient.
- Ages between 18 and older at the start of treatment.
- Pathologically or cytologically determined advanced or locally advanced Colon Cancer at Stage III/IV
- Colon cancer with measurable disease at the start of treatment
- No prior chemotherapy unless used in adjuvant therapy, completed more than 12 month ago,
- Patient has at least one quantitative measurements of at least one lesion (primary tumor or metastasis) before treatment
- Patient has at least one quantitative measurements of at least one lesion (primary tumor or metastasis) during or after the treatment.
- Patient has at least one recorded visit to the treating oncologist before treatment
- Patient has at least one recorded visit to the treating oncologist during or after the treatment.
- Treatment as per SOC for Colon cancer
- Breast Cancer:
- Genders Eligible for Study: Female patient.
- Ages between 18 and older at the start of treatment.
- Patients must have histologically confirmed breast malignancy that is either:
- Stage III breast cancer, including inflammatory breast cancer, or
- Stage IV breast cancer in a complete remission (bone only not allowed unless the bone scan is normal).
- Breast cancer with measurable disease at the start of treatment.
- No prior chemotherapy unless used in adjuvant therapy, completed more than 12 month ago.
- Patient has at least one quantitative measurements of at least one lesion (primary tumor or metastasis) before treatment.
- Patient has at least one quantitative measurements of at least one lesion (primary tumor or metastasis) during or after treatment.
- Patient has at least one recorded visit to the treating oncologist before treatment.
- Patient has at least one recorded visit to the treating oncologist during or after the treatment.
- Treatment as per SOC for Breast cancer.
- Prostate Cancer:
- Genders Eligible for Study: Male patient.
- Ages between 18 and older at the start of treatment.
- Histologically confirmed prostate cancer with progressive metastatic disease based on any of the following:
- Rise in PSA - a minimum of 3 consecutive rising levels, with an interval of ≥1 week between each determination. The last determination must have a minimal value of ≥ 2 ng/mL and be determined within two weeks prior to enrolment.
- Measurable Disease by transaxial imaging - patients showing new or progressive soft tissue masses on CT or MRI scans as defined by the PCWG2.
- Radionuclide bone scan - at least two new metastatic lesions by CT, MRI or by any SOC.
- Ongoing androgen depletion therapy with a Gonadotropin Releasing Hormone (GnRH) analogue or inhibitor, or orchiectomy (i.e., surgical or medical castration).
- Patients must have castrate levels of testosterone (<50 ng/dl [1.74 nmol/l]).
- Patient has at least one recorded visit to the treating oncologist before treatment.
- Patient has at least one recorded visit to the treating oncologist during or after the treatment.
- Treatment as per SOC for Prostate cancer.
Who cannot join
- Lung Cancer (NSCLC):
- 1. History of another malignancy within the previous 2 years except for the following:
- Adequately treated basal cell or squamous cell skin cancer,
- Adequately treated Stage I or II cancer currently in complete remission, or any other cancer that has been in complete remission for at least 2 years.
- Lung Cancer (SCLC):
- History of another malignancy within the previous 2 years except for the following: Adequately treated basal cell or squamous cell skin cancer,
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- Adequately treated Stage I or II cancer currently in complete remission, or any other cancer that has been in complete remission for at least 2 years.
- Colon Cancer:
- 1. History of another malignancy within the previous 2 years except for the following:
- Adequately treated basal cell or squamous cell skin cancer,
- Adequately treated Stage I or II cancer currently in complete remission, or any other cancer that has been in complete remission for at least 2 years.
- Breast Cancer:
- Patients who have had chemotherapy or radiotherapy within 6 weeks prior to entering the study.
- History of another malignancy within the previous 2 years except for the following:
- Adequately treated basal cell or squamous cell skin cancer,
- Adequately treated Stage I or II cancer currently in complete remission, or any other cancer that has been in complete remission for at least 2 years.
- Prostate Cancer:
- History of, or current known metastases in the brain or untreated spinal cord compression;
- History of another malignancy within the previous 2 years except for the following:
- Adequately treated basal cell or squamous cell skin cancer,
- Adequately treated Stage I or II cancer currently in complete remission, or any other cancer that has been in complete remission for at least 2 years.
- Patients have received prior cytotoxic chemotherapy for Prostate cancer.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Optimata Ltd.
Bne ‘Atarot, 60991
Marina Kleiman, PhD, 972-751-9226 ext. 112, marina@optimata.com
About this study
Official title: Multi-Centre, Multi-Indication, Two-Stage, Oncological Study to Retrospectively Assess and Prospectively Validate the Predictive Accuracy of PrediCare - a Standalone, Treatment Decision Support Software Device for Predicting Time-to-Progression in Individual Patients Under Standard of Care Treatments
This is a retrospective observational, open label study to evaluate and prospectively validate in a blind manner the accuracy of predicting treatment outcomes by PrediCare in individual patients with Non-Small Cell Lung Cancer, Small Cell Lung Cancer, Castration-Resistant Prostate Cancer, Breast Cancer \& Colon Cancer under the treatment with the mono- and combination drug protocols for the 1st and 2nd line treatment, approved to the market as a Standard of Care
Read the detailed description
The goals of this study are assessing and validating the accuracy of the PrediCare predictions by comparing them to the actual patients outcome. Study population will be composed of patients diagnosed with advanced stage disease, and divided according to the indications and treatment protocols. Retrospective data collected from patients' files will enable Optimata to compare the PrediCare Technology predictions of the pattern of metastatic and primary tumor growth and dynamics of oncological markers over time with the actual outcomes in each individual patient.
- Conditions
- Non-Small Cell Lung Cancer, Small Cell Lung Cancer, Prostate Cancer, Breast Cancer, Colon Cancer
- Being tested
- PrediCare
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma, Prostatic Neoplasms, Breast Neoplasms, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrediCareDevice
| Study group | Role | What they receive |
|---|---|---|
| Training Set | The Training Set will be used to calibrate the Predicare models and algorithms and assess its predictive potential in a retrospective manner. Patients data will be collected according to the oncological indications (NSCLC, SCLC, Prostate cancer, Breast cancer and Colon cancer) and the applied treatment protocols, and their data will be integrated and processed by the PrediCare algorithm. Receives: Device: PrediCare | |
| Validation Set | The Validation Set will be used to validate the prediction power of the device in a prospective manner. The files of patients assigned to Validation Set of the study will be used for the blind prediction of TTP under each specific treatment, based on the baseline individual information. This will be done by inputting into PrediCare the information of each individual patient, available prior to treatment onset (baseline; clinical data, imaging data, histology/cytology, oncomarkers, genetic screening, hematology, biochemistry) for creating a personalized mathematical models and predicting TTP of this specific patient. These predictions will be then compared to the clinically observed TTP for all the patients. Receives: Device: PrediCare |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary endpoint in this study is Time To Progression of disease
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2015 (estimated)
- Study startSep 2015
- Primary completionJan 2018 (estimated)
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung 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
- Retrospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Optimata Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marina Kleiman, PhD, Study director, Optimata Ltd.Irina Lazarov, MD, Principal investigator, Soroka University Medical CenterMaya Gottfried, MD, Principal investigator, Meir Medical Center, Kfar Saba, IsraelNoa Efrat (Ben-Baruch), MD, Principal investigator, Kaplan Medical Center, Rehovot, IsraelMor Moskovitz, MD, Principal investigator, Rambam Medical Center, Haifa, IsraelAvishay Sela, MD, Principal investigator, Assaf Harofeh Medical Center, Zrifin, IsraelRonen Brenner, MD, Principal investigator, Wolfson Medical CenterHovav Nehushtan, MD, Principal investigator, Hadassah Medical Center, Jerusalem
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02577627
- Sponsor's protocol ID
- OPTI-006
- Status last verified
- Sep 2016
- First submitted
- 12 Oct 2015
- Last updated
- 4 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Centre, Multi-Indication, Two-Stage, Oncological Study to Retrospectively Assess and Prospectively Validate the Predictive Accuracy of PrediCare - a Standalone, Treatment Decision Support Software Device for Predicting Time-to-Progression in Individual Patients Under Standard of Care Treatments
- ClinicalTrials.gov ID
- NCT02577627
- Acronym / sponsor ID
- OPTI-006
- Conditions
- Non-Small Cell Lung Cancer, Small Cell Lung Cancer, Prostate Cancer, Breast Cancer, Colon Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Optimata Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2015
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 16 Oct 2015 (estimated)
- 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 retrospective observational, open label study to evaluate and prospectively validate in a blind manner the accuracy of predicting treatment outcomes by PrediCare in individual patients with Non-Small Cell Lung Cancer, Small Cell Lung Cancer, Castration-Resistant Prostate Cancer, Breast Cancer \& Colon Cancer under the treatment with the mono- and combination drug protocols for the 1st and 2nd line treatment, approved to the market as a Standard of Care
Detailed description
The goals of this study are assessing and validating the accuracy of the PrediCare predictions by comparing them to the actual patients outcome. Study population will be composed of patients diagnosed with advanced stage disease, and divided according to the indications and treatment protocols. Retrospective data collected from patients' files will enable Optimata to compare the PrediCare Technology predictions of the pattern of metastatic and primary tumor growth and dynamics of oncological markers over time with the actual outcomes in each individual patient.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training Set | – | Device: PrediCareThe Training Set will be used to calibrate the Predicare models and algorithms and assess its predictive potential in a retrospective manner. Patients data will be collected according to the oncological indications (NSCLC, SCLC, Prostate cancer, Breast cancer and Colon cancer) and the applied treatment protocols, and their data will be integrated and processed by the PrediCare algorithm. |
| Validation Set | – | Device: PrediCareThe Validation Set will be used to validate the prediction power of the device in a prospective manner. The files of patients assigned to Validation Set of the study will be used for the blind prediction of TTP under each specific treatment, based on the baseline individual information. This will be done by inputting into PrediCare the information of each individual patient, available prior to treatment onset (baseline; clinical data, imaging data, histology/cytology, oncomarkers, genetic screening, hematology, biochemistry) for creating a personalized mathematical models and predicting TTP of this specific patient. These predictions will be then compared to the clinically observed TTP for all the patients. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Data from up to about 1000 NSCLC patients' files will be collected. Data from up to about 1000 SCLC patients' files will be collected. Data from up to about 1000 Colon cancer patients' files will be collected. Data from up to about 1000 Breast cancer patients' files will be collected. Data from up to about 1000 Prostate cancer patients' files will be collected.
Key inclusion criteria (58 listed)
- Gender: Female, Male.
- Age: Eighteen years and older at the start of treatment.
- Stage: Pathologically or cytologically determined advanced or locally advanced NSCLC at Stage III/IV, adenocarcinoma, OR Pathologically or cytologically determined advanced or locally advanced NSCLC at Stage III/IV, NOS.
- Lung cancer with measurable disease at the start of treatment.
- No prior chemotherapy unless used in adjuvant therapy, completed more than 12 month before.
Key exclusion criteria (22 listed)
- Adequately treated basal cell or squamous cell skin cancer,
- Adequately treated Stage I or II cancer currently in complete remission, or any other cancer that has been in complete remission for at least 2 years.
- History of another malignancy within the previous 2 years except for the following: Adequately treated basal cell or squamous cell skin cancer,
- Adequately treated Stage I or II cancer currently in complete remission, or any other cancer that has been in complete remission for at least 2 years.
- Adequately treated basal cell or squamous cell skin cancer,
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 |
|---|---|---|
| PrediCare | Device | Training Set, Validation Set |
Primary outcome
Primary endpoint in this study is Time To Progression of disease
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2017.
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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.
Marina Kleiman, PhD study director
Optimata Ltd.
Irina Lazarov, MD principal investigator
Soroka University Medical Center
Maya Gottfried, MD principal investigator
Meir Medical Center, Kfar Saba, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Small Cell Lung Cancer and Small Cell Lung Cancer, run by Optimata Ltd. at 1 site in Israel.
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 58 inclusion and 22 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 4 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. 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 Marina Kleiman, PhD (972-7519226 ext. 112, marina@optimata.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary endpoint in this study is Time To Progression of disease (time frame: 1 year). 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 4 Apr 2017.