Biopsies in Oncology - Prospective Study of Impact on Patient's Quality of Life.

Pathology Clinical Trial

Official title:

Biopsies in Oncology - Prospective Study of Impact on Patient's Quality of Life.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02334761
• Other study ID #: BIOPSy
• Status: Recruiting
• Start date: January 2014
• Est. completion date: December 2022

Study information

• Verified date: April 2022
• Source: University Health Network, Toronto
• Contact: Arundhati Shukla, B.A.
• Phone: 416-946-4501
• Email: arundhati.shukla[@]uhn.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Criteria:

Inclusion Criteria:

Patient must be =18 years old. ECOG performance status =2 (Karnofsky =60%). Life expectancy of greater than 3 months Must be undergoing a biopsy for research or diagnostic purposes. Have a diagnosis of malignancy or an assumed diagnosis of malignancy in patients where the biopsy is being performed for diagnostic purposes.

Able to complete questionnaires independently. Ability to understand and the willingness to sign a written informed consent document.

Both men and women of all races and ethnic groups are eligible for this trial. Verbal translation will be available for the consent and assistance with the questionnaires. If language is a second language or the patient is unable to read the questionnaire for any reason a family member may assist with the questionnaires.

Exclusion Criteria:

Patients who do not have a biopsy scheduled and performed.

Related Conditions & MeSH terms

• Pathology

Locations

Country	Name	City	State
Canada	Princess Margaret Cancer Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary objective is to assess the impact of research biopsies on patients quality of life.		6-8 months
Secondary	To assess the impact of diagnostic biopsies on quality of life in comparison to research biopsies		at minimum: 6 months
Secondary	To assess the true complication rates associated with biopsies		at minimum: 6 months
Secondary	To compare types of biopsies - surgical versus radiological with respect to implications on quality of life		at minimum: 6 months