Ignite Creation Date:
2025-12-24 @ 11:52 AM
Ignite Modification Date:
2026-01-01 @ 3:04 PM
Study NCT ID:
NCT02334761
Status:
COMPLETED
Last Update Posted:
2024-07-16
First Post:
2015-01-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biopsies in Oncology - Prospective Study of Impact on Patient's Quality of Life.
Sponsor:
University Health Network, Toronto
Organization:
Study Overview
Official Title:
Biopsies in Oncology - Prospective Study of Impact on Patient's Quality of Life.
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Over the past decade the paradigm of care in oncology has evolved with the advent of personalized medicine. Yet, despite this exciting prospect, there are currently only a few disease subtypes where therapeutic approaches with proven benefit exist such as EGFR (Epidermal Growth Factor Receptor) targeted therapies in EGFR-mutant lung tumours. With the increasing number of novel molecularly targeted agents available, the importance of building our understanding of cancer biology is critical.
Challenges to implement personalized medicine include the limitations of molecular testing, tumour heterogeneity and molecular evolution, costs, and the quality and morbidity associated with tumour biopsies. Sequential biopsies are essential to better understand biological markers of response and resistance, and identify predictive or prognostic markers. Despite the scientific rationale for biopsies, incorporating them into practice can be challenging, as in many cases there is no direct advantage to the patient. This project aims to understand the effect of research biopsies on the patient. The Investigator hypothesize by learning more and gaining a better appreciation of the impact on the patient, Investigators will increase the likelihood of achieving serial biopsies.
The ability to obtain serial biopsies is dependent on the patient's experience. To understand the clonal progression of cancer and validate predictive and prognostic markers of response, studies now target biopsies both at enrollment and at progression. As Investigators strive to achieve this, improving our understanding of the patient's experience will help us identify factors that positively and negatively impact on patient participation and influence the probability of successfully obtaining sequential samples.
Challenges to implement personalized medicine include the limitations of molecular testing, tumour heterogeneity and molecular evolution, costs, and the quality and morbidity associated with tumour biopsies. Sequential biopsies are essential to better understand biological markers of response and resistance, and identify predictive or prognostic markers. Despite the scientific rationale for biopsies, incorporating them into practice can be challenging, as in many cases there is no direct advantage to the patient. This project aims to understand the effect of research biopsies on the patient. The Investigator hypothesize by learning more and gaining a better appreciation of the impact on the patient, Investigators will increase the likelihood of achieving serial biopsies.
The ability to obtain serial biopsies is dependent on the patient's experience. To understand the clonal progression of cancer and validate predictive and prognostic markers of response, studies now target biopsies both at enrollment and at progression. As Investigators strive to achieve this, improving our understanding of the patient's experience will help us identify factors that positively and negatively impact on patient participation and influence the probability of successfully obtaining sequential samples.
Detailed Description:
Both primary and secondary objectives will be assessed in a questionnaire. Primary Objectives To assess the impact of research biopsies on patients quality of life.
Secondary Objectives To assess the impact of diagnostic biopsies on quality of life in comparison to research biopsies.
To assess the true complication rates associated with biopsies. To compare types of biopsies - surgical versus radiological with respect to implications on quality of life.
To assess the individual potentially modifiable factors of reason for biopsy; perceived risk; perceived benefit; wait time for biopsy; wait time for results; complications; and altruism and association with anxiety.
To determine which factors are associated with a higher and lower likelihood of achieving serial biopsies.
Secondary Objectives To assess the impact of diagnostic biopsies on quality of life in comparison to research biopsies.
To assess the true complication rates associated with biopsies. To compare types of biopsies - surgical versus radiological with respect to implications on quality of life.
To assess the individual potentially modifiable factors of reason for biopsy; perceived risk; perceived benefit; wait time for biopsy; wait time for results; complications; and altruism and association with anxiety.
To determine which factors are associated with a higher and lower likelihood of achieving serial biopsies.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: