Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02334761
Recruitment Status : Recruiting
First Posted : January 8, 2015
Last Update Posted : December 12, 2019
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

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 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
Pathology

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Other
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy




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

Secondary Outcome Measures :
  1. To assess the impact of diagnostic biopsies on quality of life in comparison to research biopsies [ Time Frame: at minimum: 6 months ]
  2. To assess the true complication rates associated with biopsies [ Time Frame: at minimum: 6 months ]
  3. To compare types of biopsies - surgical versus radiological with respect to implications on quality of life [ Time Frame: at minimum: 6 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The patient must be 18 years or older with a life expectancy of greater than 3 months. The patient must be undergoing a biopsy for research or diagnostic purposes with a diagnosis of malignancy or an assumed diagnosis of malignancy. The patient must be able to complete the questionnaires independently.
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.


Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: David Gutierrez, B. Sci 416-946-4501 ext 4821 david.gutierrez@uhn.ca

Locations
Layout table for location information
Canada, Ontario
Princess Margaret Cancer Centre Recruiting
Toronto, Ontario, Canada, M5G 1X6
Contact: David Gutierrez, B. Sci    416-946-4501 ext 4821    david.gutierrez@uhn.ca   
Principal Investigator: Amit Oza, MD         
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Layout table for investigator information
Principal Investigator: Amit Oza, MD University Health Network, Toronto
Layout table for additonal information
Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT02334761    
Other Study ID Numbers: BIOPSy
First Posted: January 8, 2015    Key Record Dates
Last Update Posted: December 12, 2019
Last Verified: December 2019
Keywords provided by University Health Network, Toronto:
Biopsy