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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	19 April 2022
Main ID:	NCT02334761
Date of registration:	06/01/2015
Prospective Registration:	No
Primary sponsor:	University Health Network, Toronto
Public title:	Biopsies in Oncology - Prospective Study of Impact on Patient's Quality of Life.
Scientific title:	Biopsies in Oncology - Prospective Study of Impact on Patient's Quality of Life.
Date of first enrolment:	January 2014
Target sample size:	400
Recruitment status:	Recruiting
URL:	https://clinicaltrials.gov/show/NCT02334761
Study type:	Observational
Study design:
Phase:

Countries of recruitment
Canada

Contacts

Name:	Amit Oza, MD
Address:
Telephone:
Email:
Affiliation:	University Health Network, Toronto

Name:	David Gutierrez, B. Sci
Address:
Telephone:	416-946-4501
Email:	arundhati.shukla@uhn.ca
Affiliation:

Name:	Arundhati Shukla, B.A.
Address:
Telephone:	416-946-4501
Email:	arundhati.shukla@uhn.ca
Affiliation:

Key inclusion & exclusion criteria

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.

Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Pathology

Intervention(s)

Primary Outcome(s)

The primary objective is to assess the impact of research biopsies on patients quality of life. [Time Frame: 6-8 months]

Secondary Outcome(s)

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]

Secondary ID(s)

BIOPSy

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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