Colorectal CancerNCT01703585
Feasibility Study of Genomic Profiling Methods and Timing in Tumor Samples
An observational study of Colorectal Cancer and Breast Cancer, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
This is a feasibility study to look for genetic alterations in tissue and blood samples that may be useful in determining what treatments may be useful in the patient's cancer care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Breast Cancer, Gynecological Cancer
- How many people
- 45 participants
- Where
- 1 siteCanada
- Study dates
- 4 Oct 2012to 1 May 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
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: metastatic breast, colorectal, gynecological cancer or melanoma
Who may be able to join
- Age ≥ 18 years.
- Histological or cytological proof of either metastatic breast, colorectal, gynecological or melanoma malignancy.
- At least one biopsiable lesion deemed medically accessible and safe to biopsy.
- Candidate for one or more phase I or II clinical trials at the time of study enrollment or at a later time point.
- Fulfills local institution's laboratory parameters for tumor biopsy.
- Willingness and ability of patient to provide signed voluntary informed consent.
Who cannot join
- Any condition that could interfere with a patient's ability to provide informed consent such as dementia or severe cognitive impairment.
- Any contraindication to undergoing a biopsy procedure.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Feasibility Study of Genomic Profiling Methods and Timing of Sample Collection to Evaluate Clonal Evolution and Tumor Heterogeneity
This is a feasibility study to look for genetic alterations in tissue and blood samples that may be useful in determining what treatments may be useful in the patient's cancer care.
Read the detailed description
As part of the study, patients will have archival tumor tissue collected, and have tumor biopsies and blood samples taken. The samples will be tested for genetic alterations, and the results will be discussed with the patient including potential treatments. If patients agree, after they have received treatment for their cancer and their disease progresses, a second biopsy procedure will be done.
- Conditions
- Colorectal Cancer, Breast Cancer, Gynecological Cancer, Metastatic, Eligible for Phase I or Phase II Study, Melanoma Cancer
- Keywords
- genomic analysis, genome, tumor, tissue, archival, biopsy, core needle, fine needle, DNA, gene, expression, sequencing
- Medical subject headings
- Colorectal Neoplasms, Breast Neoplasms, Neoplasm Metastasis, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| metastatic breast cancer | Not described | |
| metastatic colorectal cancer | Not described | |
| metastatic gynecological cancer | Not described | |
| metastatic melanoma | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient recruitment for paired core and fine needle biopsy greater than or equal to 50% of those screened or approached.
Measured: 2 years
Secondary outcomes (5)
The rate of acceptable tumor samples from fresh core needle biopsy samples/total number of fresh core needle biopsy samples greater than or equal to 90%
Measured: 2 years
The rate of acceptable tumor samples from fresh fine needle biopsy samples/total number of fresh fine needle biopsy samples greater than or equal to 50%
Measured: 2 years
Successful analysis of fresh core needle biopsy samples and fresh fine needle biopsy samples greater than or equal to 50%
Sequenom or MiSeq/TSCAP and MiSeq/NGS
Measured: 2 years
Analysis of fresh core needle biopsy samples and fresh fine needle biopsy samples from time from patient recruitment to final results, less than a defined period of time, in greater than or equal to 90%
Sequenom or MiSeq/TSCAP analysis from fresh core needle biopsy samples less than 4 weeks; sequenom or MiSeq/TSCAP analysis from fresh fine needle biopsy samples less than 8 weeks; MiSeq/NGS analysis from fresh core needle biopsy samples less than 8 weeks; MiSeq/NGS analysis from fresh fine needle biopsy samples less than 8 weeks
Measured: 2 years
Actionable genomic result analysis of fresh core needle biopsy samples and fresh fine needle biopsy samples greater than or equal to 30%
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2012 (estimated)
- Study start4 Oct 2012
- Primary completion1 May 2018
- Study completion1 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal 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
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Ontario Institute for Cancer Research, Princess Margaret Hospital, Canada
- Responsible party
- Sponsor
- Investigators
- Lillian Siu, MD, Principal investigator, Princess Margaret Cancer CentreBedard Philippe, MD, Principal investigator, Princess Margaret Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01703585
- Sponsor's protocol ID
- MATCH-001
- Status last verified
- May 2018
- First submitted
- 5 Oct 2012
- Last updated
- 9 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study of Genomic Profiling Methods and Timing of Sample Collection to Evaluate Clonal Evolution and Tumor Heterogeneity
- ClinicalTrials.gov ID
- NCT01703585
- Acronym / sponsor ID
- MATCH-001
- Conditions
- Colorectal Cancer, Breast Cancer, Gynecological Cancer, Metastatic, Eligible for Phase I or Phase II Study, Melanoma Cancer
- Keywords
- genomic analysis, genome, tumor, tissue, archival, biopsy, core needle, fine needle
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Ontario Institute for Cancer Research, Princess Margaret Hospital, Canada
- Study start
- 4 Oct 2012 (actual)
- Primary completion
- 1 May 2018 (actual)
- Study completion
- 1 May 2018 (actual)
- First posted
- 10 Oct 2012 (estimated)
- 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.
This is a feasibility study to look for genetic alterations in tissue and blood samples that may be useful in determining what treatments may be useful in the patient's cancer care.
Detailed description
As part of the study, patients will have archival tumor tissue collected, and have tumor biopsies and blood samples taken. The samples will be tested for genetic alterations, and the results will be discussed with the patient including potential treatments. If patients agree, after they have received treatment for their cancer and their disease progresses, a second biopsy procedure will be done.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| metastatic breast cancer | – | – |
| metastatic colorectal cancer | – | – |
| metastatic gynecological cancer | – | – |
| metastatic melanoma | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- metastatic breast, colorectal, gynecological cancer or melanoma
Key inclusion criteria (6 listed)
- Age ≥ 18 years.
- Histological or cytological proof of either metastatic breast, colorectal, gynecological or melanoma malignancy.
- At least one biopsiable lesion deemed medically accessible and safe to biopsy.
- Candidate for one or more phase I or II clinical trials at the time of study enrollment or at a later time point.
- Fulfills local institution's laboratory parameters for tumor biopsy.
Key exclusion criteria (2 listed)
- Any condition that could interfere with a patient's ability to provide informed consent such as dementia or severe cognitive impairment.
- Any contraindication to undergoing a biopsy procedure.
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
Patient recruitment for paired core and fine needle biopsy greater than or equal to 50% of those screened or approached.
Time frame: 2 years
5 secondary outcomes
The rate of acceptable tumor samples from fresh core needle biopsy samples/total number of fresh core needle biopsy samples greater than or equal to 90%
Time frame: 2 years
The rate of acceptable tumor samples from fresh fine needle biopsy samples/total number of fresh fine needle biopsy samples greater than or equal to 50%
Time frame: 2 years
Successful analysis of fresh core needle biopsy samples and fresh fine needle biopsy samples greater than or equal to 50%
Time frame: 2 years
Analysis of fresh core needle biopsy samples and fresh fine needle biopsy samples from time from patient recruitment to final results, less than a defined period of time, in greater than or equal to 90%
Time frame: 2 years
Actionable genomic result analysis of fresh core needle biopsy samples and fresh fine needle biopsy samples greater than or equal to 30%
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2018.
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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. This study is not recruiting at the moment.
Lillian Siu, MD principal investigator
Princess Margaret Cancer Centre
Bedard Philippe, 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 Colorectal 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 6 inclusion and 2 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: finished, as of the sponsor's last update on 9 May 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient recruitment for paired core and fine needle biopsy greater than or equal to 50% of those screened or approached. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 May 2018.