Genomic Investigation of Unusual Responders

NCT ID: NCT03740503

Last Updated: 2025-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-11-01

Study Completion Date

2025-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David Cescon, MD

Role: PRINCIPAL_INVESTIGATOR

Princess Margaret Cancer Centre

Locations

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Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Celeste Yu

Role: CONTACT

416-946-4501 ext. 5281

Elizabeth Shah

Role: CONTACT

416-946-4501 ext. 3833

Facility Contacts

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Celeste Yu

Role: primary

416-946-4501 ext. 5281

Elizabeth Shah

Role: backup

416-946-4501 ext. 3833

References

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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.

Reference Type DERIVED
PMID: 32912664 (View on PubMed)

Other Identifiers

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GENIUS

Identifier Type: -

Identifier Source: org_study_id

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