Clinical Trials Logo

Clinical Trial Summary

This pilot clinical trial aims to assess the real world quality of life and survival of patients treated with therapy that has preliminary evidence of efficacy but uncertainty of the magnitude of clinical benefit or cost effectiveness in subjects with cancer. The goal of this study is to collect real world evidence with respect to quality of life and outcomes to support decision making.

Clinical Trial Description

Clinical practice involves incorporating new data into treatment recommendations including non randomized phase I/II studies. Clinicians' decision-making is swayed by alternative endpoints like response rate (RR), depth of response and progression free survival (PFS), presumed to be surrogates for overall survival (OS). Determination of the added value of these new therapies in terms of outcomes and quality of life (QOL) is challenging in the absence of comparators in trials resulting in increased uncertainty in terms of outcomes, quality of life and cost-effectiveness. With the possibility of a randomized clinical trial evidence being low in certain populations, the use of real world data (RWD) can provide information regarding therapies with preliminary evidence of efficacy but uncertainty of the magnitude of clinical benefit or cost effectiveness. With RWD, patients may receive access to therapies and participate in the evidence generation package. This study proposes to use RWD to generate evidence to evaluate therapies with preliminary evidence of efficacy but uncertainty of the magnitude of clinical benefit or cost effectiveness. The key components include regular interval disease assessments (eg radiographic imaging) and collection of PROs using standardized QOL questionnaires. The aim is to provide high quality real world evidence (RWE) for assessment and economic modelling to reduce uncertainty and facilitate decision-making. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT06242912
Study type Interventional
Source British Columbia Cancer Agency
Contact Cheryl Ho, MD
Phone 604 877 6000
Status Recruiting
Phase N/A
Start date January 22, 2024
Completion date January 2029

See also
  Status Clinical Trial Phase
Recruiting NCT05346796 - Survivorship Plan HEalth REcord (SPHERE) Implementation Trial N/A
Recruiting NCT05094804 - A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents Phase 1/Phase 2
Completed NCT04867850 - Effect of Behavioral Nudges on Serious Illness Conversation Documentation N/A
Enrolling by invitation NCT04086251 - Remote Electronic Patient Monitoring in Oncology Patients N/A
Completed NCT01285037 - A Study of LY2801653 in Advanced Cancer Phase 1
Completed NCT00680992 - Study of Denosumab in Subjects With Giant Cell Tumor of Bone Phase 2
Completed NCT00062842 - Study of Irinotecan on a Weekly Schedule in Children Phase 1
Active, not recruiting NCT04548063 - Consent Forms in Cancer Research: Examining the Effect of Length on Readability N/A
Completed NCT04337203 - Shared Healthcare Actions and Reflections Electronic Systems in Survivorship N/A
Recruiting NCT04349293 - Ex-vivo Evaluation of the Reactivity of the Immune Infiltrate of Cancers to Treatments With Monoclonal Antibodies Targeting the Immunomodulatory Pathways N/A
Terminated NCT02866851 - Feasibility Study of Monitoring by Web-application on Cytopenia Related to Chemotherapy N/A
Active, not recruiting NCT05304988 - Development and Validation of the EFT for Adolescents With Cancer
Completed NCT00340522 - Childhood Cancer and Plexiform Neurofibroma Tissue Microarray for Molecular Target Screening and Clinical Drug Development
Recruiting NCT04843891 - Evaluation of PET Probe [64]Cu-Macrin in Cardiovascular Disease, Cancer and Sarcoidosis. Phase 1
Active, not recruiting NCT03844048 - An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial Phase 3
Completed NCT03109041 - Initial Feasibility Study to Treat Resectable Pancreatic Cancer With a Planar LDR Source Phase 1
Completed NCT03167372 - Pilot Comparison of N-of-1 Trials of Light Therapy N/A
Terminated NCT01441115 - ECI301 and Radiation for Advanced or Metastatic Cancer Phase 1
Recruiting NCT06206785 - Resting Energy Expenditure in Palliative Cancer Patients
Recruiting NCT05318196 - Molecular Prediction of Development, Progression or Complications of Kidney, Immune or Transplantation-related Diseases