Advanced CancerNCT01443390
An Ancillary Pilot Trial Using Whole Genome Sequencing In Patients With Advance Refractory Cancer
An observational study of Advanced Cancer, run by Scottsdale Healthcare at 1 site in United States.
Trial summary
When a patient with advanced cancer consults with a member of the Phase I drug development team, the investigators utilize all information possible to try to select a therapy for that patient which has the best chance of working for them. This information includes: 1. Past published information 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Mar 2013
- 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: Patients with advanced refractory cancer
Who may be able to join
- Have a life expectancy of greater than 3 months.
- Patients must have a diagnosis of histologically or cytologically confirmed advanced incurable cancer which has progressed on one or more prior chemotherapeutic, hormonal or biological regimens for advanced disease.
- Be a good medical candidate for and willing to undergo a biopsy or surgical procedure to obtain tissue, which may or may not be part of the patient's routine care for their malignancy.
Who cannot join
- Patients with symptomatic CNS metastasis.
- Known HIV, HBV or HCV infection requiring antiviral therapy.
- Pregnant or breast-feeding patients or any patient with childbearing potential not using adequate contraception.
- Inaccessible tumor for biopsy
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia G. Piper Cancer Center Clinical Trials at Scottsdale Healthcare
Scottsdale, Arizona, 85258
About this study
Official title: An Ancillary Pilot Trial Using Whole Genome Sequencing In Patients With Advanced Refractory Cancer
When a patient with advanced cancer consults with a member of the Phase I drug development team, the investigators utilize all information possible to try to select a therapy for that patient which has the best chance of working for them. This information includes:
- Past published information
- Clinical experience and judgement
- Immunohistochemistry for specific targets (e.g., ER)
- Standard sequencing (e.g., for K-Ras) and other methods now available.
The investigators have a new tool which warrants early exploration for what role it might eventually play in the process of selecting the best therapy for an individual patient. The basis of the current ancillary exploratory study is to gain initial experience with the operational aspects of this whole genome sequencing in this setting.
Read the detailed description
- To measure the time from biopsy to completion and final analysis of Whole Genome Sequencing (WGS) on patient tumor and non-tumor samples.
- To examine the frequency with which useable sequence data is obtained as a function of tumor volume received and percent tumor involvement in the biopsy
- To identify the frequency with which potential targets and pathways for therapy are discovered.
- To observe for any evidence that if anti-tumor activity from treatment is noted how would the genome sequencing have correlated with that activity.
- Conditions
- Advanced Cancer
- Keywords
- Whole genome sequencing, Advanced Refractory Cancer
What is being measured
The primary outcome is the main question the study is designed to answer.
to identify as many genomic changes as possible in advanced cancers, so as to expand the range of potential actionable targets with therapies that were commercially available or clinical trials
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2011 (estimated)
- Study startSep 2011
- Primary completionMar 2013
- Study completionMar 2013
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 Advanced CancerStudies of the same condition, open and under way.
- 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
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scottsdale Healthcare
- Sponsor type
- University, hospital or other
- Collaborators
- National Foundation for Cancer Research, Translational Genomics Research Institute
- Responsible party
- Principal investigator, Glen Weiss, Cancer Treatment Centers of America
- Investigators
- Glen J Weiss, M.D., Principal investigator, Scottsdale Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01443390
- Sponsor's protocol ID
- SCRI-CA_004
- Status last verified
- May 2014
- First submitted
- 27 Sep 2011
- Last updated
- 14 May 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Weiss GJ, Liang WS, Demeure MJ, Kiefer JA, Hostetter G, Izatt T, Sinari S, Christoforides A, Aldrich J, Kurdoglu A, Phillips L, Benson H, Reiman R, Baker A, Marsh V, Von Hoff DD, Carpten JD, Craig DW. A pilot study using next-generation sequencing in advanced cancers: feasibility and challenges. PLoS One. 2013 Oct 30;8(10):e76438. doi: 10.1371/journal.pone.0076438. eCollection 2013.
PubMed 24204627
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Ancillary Pilot Trial Using Whole Genome Sequencing In Patients With Advanced Refractory Cancer
- ClinicalTrials.gov ID
- NCT01443390
- Acronym / sponsor ID
- SCRI-CA_004
- Conditions
- Advanced Cancer
- Keywords
- Whole genome sequencing, Advanced Refractory Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Scottsdale HealthcareUniversity, hospital or other
- Collaborators
- National Foundation for Cancer Research, Translational Genomics Research Institute
- Study start
- Sep 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 29 Sep 2011 (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.
When a patient with advanced cancer consults with a member of the Phase I drug development team, the investigators utilize all information possible to try to select a therapy for that patient which has the best chance of working for them. This information includes:
- Past published information
- Clinical experience and judgement
- Immunohistochemistry for specific targets (e.g., ER)
- Standard sequencing (e.g., for K-Ras) and other methods now available.
The investigators have a new tool which warrants early exploration for what role it might eventually play in the process of selecting the best therapy for an individual patient. The basis of the current ancillary exploratory study is to gain initial experience with the operational aspects of this whole genome sequencing in this setting.
Detailed description
- To measure the time from biopsy to completion and final analysis of Whole Genome Sequencing (WGS) on patient tumor and non-tumor samples.
- To examine the frequency with which useable sequence data is obtained as a function of tumor volume received and percent tumor involvement in the biopsy
- To identify the frequency with which potential targets and pathways for therapy are discovered.
- To observe for any evidence that if anti-tumor activity from treatment is noted how would the genome sequencing have correlated with that activity.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with advanced refractory cancer
Key inclusion criteria (3 listed)
- Have a life expectancy of greater than 3 months.
- Patients must have a diagnosis of histologically or cytologically confirmed advanced incurable cancer which has progressed on one or more prior chemotherapeutic, hormonal or biological regimens for advanced disease.
- Be a good medical candidate for and willing to undergo a biopsy or surgical procedure to obtain tissue, which may or may not be part of the patient's routine care for their malignancy.
Key exclusion criteria (4 listed)
- Patients with symptomatic CNS metastasis.
- Known HIV, HBV or HCV infection requiring antiviral therapy.
- Pregnant or breast-feeding patients or any patient with childbearing potential not using adequate contraception.
- Inaccessible tumor for biopsy
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
to identify as many genomic changes as possible in advanced cancers, so as to expand the range of potential actionable targets with therapies that were commercially available or clinical trials
Time frame: 12 months
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 14 May 2014.
- Results publication: PubMed 24204627Weiss GJ, Liang WS, Demeure MJ, Kiefer JA, Hostetter G, Izatt T, Sinari S, Christoforides A, Aldrich J, Kurdoglu A, Phillips L, Benson H, Reiman R, Baker A, Marsh V, Von Hoff DD, Carpten JD, Craig DW. A pilot study using next-generation sequencing in advanced cancers: feasibility and challenges. PLoS One. 2013 Oct 30;8(10):e76438. doi: 10.1371/journal.pone.0076438. eCollection 2013.
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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.
Glen J Weiss, M.D. principal investigator
Scottsdale Healthcare
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 Advanced Cancer, run by Scottsdale Healthcare at 1 site in United States.
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 3 inclusion and 4 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 14 May 2014. 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 United States. 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?
to identify as many genomic changes as possible in advanced cancers, so as to expand the range of potential actionable targets with therapies that were commercially available or clinical trials (time frame: 12 months). 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 NCT01443390, 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 14 May 2014.