Clinical trial NCT03740503: Genomic Investigation of Unusual Responders
Official title: Genomic Investigation of Unusual Responders
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer
Breast Cancer
Non-small Cell Lung Cancer
Colorectal Cancer
Genitourinary Cancer
Gynecological Cancer
Upper Aerodigestive Tract Cancer
Pancreatobiliary Gastrointestinal Cancer
Melanoma (Skin)
Rare Cancer
Carcinoma of Unknown Primary
Keywords: Cancer
Breast Cancer
Non- small Cell Lung Cancer
Colorectal Cancer
Genitourinary Cancer
Gynecological Cancer
Upper Aerodigestive Tract Cancer
Pancreatobiliary Gastrointestinal Cancer
Melanoma Cancer
Rare Cancer
Unknown Primary Cancer
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2018-11-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients enrolled who displayed exceptional response as well as those who were expected to respond favourably but displayed a poor outcome (e.g. drastic tumour growth or death) to their prescribed medication or treatment from a clinical trial.

Brief summary: Studies have shown that tumors from the same patient may respond very differently to the same therapeutic agents. This study aims to investigate the genetic basis of tumors that respond abnormally well or poorly to therapeutic agents in an effort to understand the fundamental genetic basis of this response. The present protocol seeks to retrospectively perform Exome, next-generation (DNA) sequencing and/or other molecular techniques on tumor samples to identify the genetic basis of a patient's exceptional response to chemotherapy.


Eligibility criteria: Inclusion Criteria:

1. The patient must have either an exceptionally good or poor response to treatment, as indicated by their treating physician.

   1. The exact definition of this is adaptable to the disease but a suggested guideline is a Complete Response, Partial Response or progression free interval of at least 6 months
   2. Exceptionally poor response includes patients who were expected to respond favourably to a treatment but instead responded poorly (e.g dramatic tumor growth or death)
2. The patient must have sufficient archival tumor available for sequencing.
3. Deceased patients will also be considered for analysis (up to 30 patients per year) if they meet at least one of the following requirements:

   a)) Patients who have archival tissue stored within the UHN Laboratory Medicine Program who have had a consent waiver granted by the REB to access the tissue.

   b) Patients who have archival tissue banked for further research within the UHN Biospecimen Sciences Program

   Exclusion Criteria:
   * None

Primary outcomes:
measure: Genomic Characterization of Tumor Samples
timeFrame: Through study completion, up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
Study officials:
affiliation: Princess Margaret Cancer Centre
name: David Cescon, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Madariaga A, Garg S, Bruce JP, Thiryayi S, Mandilaras V, Rath P, Oza AM, Dhani NC, Cescon DW, Lee YC, Chen E, Wang L, Clarke B, Lheureux S. Biomarkers of outcome to weekly paclitaxel in epithelial ovarian cancer. Gynecol Oncol. 2020 Nov;159(2):539-545. doi: 10.1016/j.ygyno.2020.08.032. Epub 2020 Sep 8.