CancerGENIUSNCT03740503
Genomic Investigation of Unusual Responders
An observational study of Cancer and Breast Cancer, run by University Health Network, Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Breast Cancer, Non-small Cell Lung Cancer
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 1 Nov 2013to Nov 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- The patient must have either an exceptionally good or poor response to treatment, as indicated by their treating physician.
- 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
- 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)
- The patient must have sufficient archival tumor available for sequencing.
- 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.
- Patients who have archival tissue banked for further research within the UHN Biospecimen Sciences Program
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9
Celeste Yu, 416-946-4501 ext. 5281, celeste.yu@uhn.ca
Elizabeth Shah, 416-946-4501 ext. 3833, elizabeth.shah@uhn.ca
About this study
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.
- Conditions
- Cancer, Breast Cancer, Non-small Cell Lung Cancer, Colorectal Cancer, Genitourinary Cancer, Gynecological Cancer
- 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
- Medical subject headings
- Neoplasms, Breast Neoplasms, Carcinoma, Non-Small-Cell Lung, Colorectal Neoplasms, Urogenital Neoplasms, Melanoma, Neoplasms, Unknown Primary
What is being measured
The primary outcome is the main question the study is designed to answer.
Genomic Characterization of Tumor Samples
Characterization of the genetic changes that may explain a tumor's exceptional response or disaster to therapeutc agents.
Measured: Through study completion, up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2018
- Study start1 Nov 2013
- Primary completionNov 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Cescon, MD, Principal investigator, Princess Margaret Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03740503
- Sponsor's protocol ID
- GENIUS
- Acronym
- GENIUS
- Status last verified
- Jan 2025
- First submitted
- 23 Oct 2018
- Last updated
- 31 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32912664
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genomic Investigation of Unusual Responders
- ClinicalTrials.gov ID
- NCT03740503
- Acronym / sponsor ID
- GENIUS / GENIUS
- Conditions
- Cancer, Breast Cancer, Non-small Cell Lung Cancer, Colorectal Cancer, Genitourinary Cancer, Gynecological Cancer
- Keywords
- Cancer, Breast Cancer, Non- small Cell Lung Cancer, Colorectal Cancer, Genitourinary Cancer, Gynecological Cancer, Upper Aerodigestive Tract Cancer, Pancreatobiliary Gastrointestinal Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 1 Nov 2013 (actual)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 14 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- The patient must have either an exceptionally good or poor response to treatment, as indicated by their treating physician.
- The patient must have sufficient archival tumor available for sequencing.
- 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.
Key exclusion criteria (1 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Genomic Characterization of Tumor Samples
Time frame: Through study completion, up to 2 years
Characterization of the genetic changes that may explain a tumor's exceptional response or disaster to therapeutc agents.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2025.
- Derived from this study: PubMed 32912664Madariaga 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.
Related trials for Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David Cescon, MD principal investigator
Princess Margaret Cancer Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Breast Cancer, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Celeste Yu (416-946-4501 ext. 5281, celeste.yu@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Genomic Characterization of Tumor Samples (time frame: Through study completion, up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03740503, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2025.