Biopsies in Oncology - Prospective Study of Impact on Patient's Quality of Life.
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|ClinicalTrials.gov Identifier: NCT02334761|
Recruitment Status : Recruiting
First Posted : January 8, 2015
Last Update Posted : December 12, 2019
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 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.
|Condition or disease|
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.
|Study Type :||Observational|
|Estimated Enrollment :||400 participants|
|Official Title:||Biopsies in Oncology - Prospective Study of Impact on Patient's Quality of Life.|
|Study Start Date :||January 2014|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
- The primary objective is to assess the impact of research biopsies on patients quality of life. [ Time Frame: 6-8 months ]
- To assess the impact of diagnostic biopsies on quality of life in comparison to research biopsies [ Time Frame: at minimum: 6 months ]
- To assess the true complication rates associated with biopsies [ Time Frame: at minimum: 6 months ]
- To compare types of biopsies - surgical versus radiological with respect to implications on quality of life [ Time Frame: at minimum: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02334761
|Contact: David Gutierrez, B. Sci||416-946-4501 ext email@example.com|
|Princess Margaret Cancer Centre||Recruiting|
|Toronto, Ontario, Canada, M5G 1X6|
|Contact: David Gutierrez, B. Sci 416-946-4501 ext 4821 firstname.lastname@example.org|
|Principal Investigator: Amit Oza, MD|
|Principal Investigator:||Amit Oza, MD||University Health Network, Toronto|