Multi-Indication, Retrospective Oncological Study to Validate the Accuracy in Predicting TTP by PrediCare in Patients Under SOC

NCT02577627 | Unknown

• 1 other identifier: OPTI-006
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

Brief 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 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

Conditions

Non-Small Cell Lung Cancer; Small Cell Lung Cancer; Prostate Cancer; Breast Cancer; Colon Cancer

Outcome Measures

Primary Outcomes (1)

• Primary endpoint in this study is Time To Progression of disease

  1 year

Study Arms (2)

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.

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.

Device: PrediCare

Interventions

PrediCare DEVICE

Training Set; Validation Set

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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.
• 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.

You may not qualify if:

• Lung Cancer (NSCLC):
• \. 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,
• 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:
• \. 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,

Sponsors & Collaborators

• Optimata Ltd.: lead

Study Sites (1)

Optimata Ltd.

Bne ‘Atarot, 60991, Israel

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Small Cell Lung Carcinoma; Prostatic Neoplasms; Breast Neoplasms; Colonic Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Marina Kleiman, PhD

  Optimata Ltd.

  STUDY DIRECTOR

• Irina Lazarov, MD

  Soroka University Medical Center

  PRINCIPAL INVESTIGATOR

• Maya Gottfried, MD

  Meir Medical Center, Kfar Saba, Israel

  PRINCIPAL INVESTIGATOR

• Noa Efrat (Ben-Baruch), MD

  Kaplan Medical Center, Rehovot, Israel

  PRINCIPAL INVESTIGATOR

• Mor Moskovitz, MD

  Rambam Medical Center, Haifa, Israel

  PRINCIPAL INVESTIGATOR

• Avishay Sela, MD

  Assaf Harofeh Medical Center, Zrifin, Israel

  PRINCIPAL INVESTIGATOR

• Ronen Brenner, MD

  Wolfson Medical Center

  PRINCIPAL INVESTIGATOR

• Hovav Nehushtan, MD

  Hadassah Medical Center, Jerusalem

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marina Kleiman, PhD

CONTACT

972-7519226; marina@optimata.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2015
• First Posted: October 16, 2015
• Study Start: September 1, 2015
• Primary Completion: January 1, 2018
• Study Completion: September 1, 2019
• Last Updated: April 4, 2017

Record last verified: 2016-09

Locations

IL (1)