Stage III and IV Glioma PatientsNCT02558335
CTCs for High Grade Glioma
An observational study of Stage III and IV Glioma Patients, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial summary
The purpose of this study is to identify and quantify circulating tumor markers, which are associated with the presence of tumors. The current imaging available does not allow specificity of tumor size as it relates to pseudoprogression (a temporary enlargement or "swelling" of the tumor after treatment before it… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stage III and IV Glioma Patients
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Apr 2020
- 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: 1. Patients with grade III and IV glioma
Who may be able to join
- Patients with biopsy-proven high grade glioma who are undergoing definitive radiotherapy as a part of their treatment regimen or patients with radiographic appearance of high grade glioma
- Age 18 or older
- Signed informed consent
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Circulating Tumor Markers for High Grade Glioma
The purpose of this study is to identify and quantify circulating tumor markers, which are associated with the presence of tumors. The current imaging available does not allow specificity of tumor size as it relates to pseudoprogression (a temporary enlargement or "swelling" of the tumor after treatment before it shrinks). Our hope is that CTCs will provide a more accurate description of tumor state for high grade glioma patients.
- Conditions
- Stage III and IV Glioma Patients
What is being measured
The primary outcome is the main question the study is designed to answer.
to identify and quantify circulating tumor markers
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2015 (estimated)
- Study startApr 2013
- Primary completionApr 2017
- Study completionApr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage III and IV Glioma PatientsStudies 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Lustig, MD, Principal investigator, Abramsvaniaon Cancer Center of the University of Pennsyl
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02558335
- Sponsor's protocol ID
- UPCC 09313
- Status last verified
- Apr 2020
- First submitted
- 19 Aug 2015
- Last updated
- 24 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circulating Tumor Markers for High Grade Glioma
- ClinicalTrials.gov ID
- NCT02558335
- Acronym / sponsor ID
- UPCC 09313
- Conditions
- Stage III and IV Glioma Patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Study start
- Apr 2013 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2020 (actual)
- First posted
- 24 Sep 2015 (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.
The purpose of this study is to identify and quantify circulating tumor markers, which are associated with the presence of tumors. The current imaging available does not allow specificity of tumor size as it relates to pseudoprogression (a temporary enlargement or "swelling" of the tumor after treatment before it shrinks). Our hope is that CTCs will provide a more accurate description of tumor state for high grade glioma patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 1. Patients with grade III and IV glioma
Key inclusion criteria (3 listed)
- Patients with biopsy-proven high grade glioma who are undergoing definitive radiotherapy as a part of their treatment regimen or patients with radiographic appearance of high grade glioma
- Age 18 or older
- Signed informed consent
Key exclusion criteria (0 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
to identify and quantify circulating tumor markers
Time frame: 3 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 24 Apr 2020.
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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.
Robert Lustig, MD principal investigator
Abramsvaniaon Cancer Center of the University of Pennsyl
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 Stage III and IV Glioma Patients, run by Abramson Cancer Center at Penn Medicine 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 0 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 24 Apr 2020. 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 and quantify circulating tumor markers (time frame: 3 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 24 Apr 2020.