Hyper-Personalized Medicine Using Patient Derived Xenografts (PDXovo) for Metastatic Solid Tumors

NCT04602702 | Unknown DMC

• 1 other identifier: SUN-2047
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The Investigators will use novel PDX (patient-derived xenograft) technology to form xenografts using material from metastatic solid tumor patients. Xenografts will be treated with a panel of drugs to determine which agent(s) yield the greatest anti-tumor effect on the xenograft.

Conditions

Kidney Neoplasm; Carcinoma, Renal Cell; Metastatic Solid Tumor

Keywords

hyper-personalized medicine; patient derived xenograft; chick embryo

Outcome Measures

Primary Outcomes (3)

• Objective Response

  Complete Response, Partial Response

  3-9 months

• Stable Disease Response

  3-9 months

• Progressive Disease Response

  3-9 months

Eligibility Criteria

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

Study Population

Patients with metastatic solid tumors identified at Sunnybrook Health Sciences Centre - Odette Cancer Centre

You may qualify if:

• i) Age 18+ ii) localized solid tumor irrespective of subtype undergoing curative surgery iii) Consent to provide tumor tissue for this research
• i) Age 18+ ii) metastatic cancer irrespective of subtype undergoing a needle biopsy or resection of lung, liver or brain as part of their routine clinical care.
• iii) metastatic cancer irrespective of disease site undergoing a thoracentesis or paracentesis as part of their routine clinical care.
• iv) measurable disease as per RECIST 1.1 criteria v) Consent to provide tumor tissue for this research

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Odette Cancer Centre

Toronto, Ontario, M4N 3M5, Canada

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

metastasectomy specimens, needle core biopsies, thoracentesis, paracentesis

MeSH Terms

Conditions

Kidney Neoplasms; Carcinoma, Renal Cell; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Georg Bjarnason, MD

  Sunnybrook Hospital/Odette Cancer Centre

  PRINCIPAL INVESTIGATOR

• Elyse Watkins, BSc, PGDip

  Sunnybrook Hospital/Odette Cancer Centre

  STUDY DIRECTOR

• Nir Lipsman, MD

  Sunnybrook Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hon S Leong, PhD

CONTACT

416-480-6100; hon.leong@sri.utoronto.ca

Sue Santillo

CONTACT

416-480-6100; sue.santillo@sunnybrook.ca

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2020
• First Posted: October 26, 2020
• Study Start: December 1, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: April 5, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)