Diffuse Large B-cell LymphomaNCT00754117
Early Response Assessment in Diffuse Large B-Cell Lymphoma (DLCL) Patients by 18-fluoro-2-deoxyglycose Positron Emission Tomography (FDG-PET)
An observational study of Diffuse Large B-cell Lymphoma, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
Newly diagnosed DLCL patients will have baselne FDG-PET as part of initial staging (PET-1). Patients will then undergo 2 cycles of chemotherapy with R/CHOP. 14 to 21 days following cycle 2 of R/CHOP, patients will undergo repeat FDG-PET scan (PET-2). They will then complete therapy as planned. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diffuse Large B-cell Lymphoma
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to 8 Dec 2012
- 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: Newly diagnosed diffuse large b cell lymphoma patients planning to receive 6-8 cycles of R/CHOP chemotherapy.
Who may be able to join
- Patients must have histologically or cytologically confirmed diagnosis of CD20+ diffuse large B cell lymphoma (LBCL) of any stage, including subtypes mediastinal large B cell, centroblastic, immunoblastic, T cell rich B cell and anaplastic B cell lymphoma
- Patients must have received no prior anti-lymphoma therapy.
- Age >18 years.
- Patients must have a treatment plan to include R/CHOP or R/CHOP followed by radiotherapy.
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Patients who have known HIV infection.
- Patients who are, in the opinion of their treating oncologist, unable to undergo R/CHOP chemotherapy.
Trial locations and contacts
1 site in 1 country.
United States1 site
Weill Cornell Medical College
New York, New York, 10021
About this study
Official title: Early Response Assessment in Patients With Diffuse Large B-cell Lymphoma Using 18-fluoro-2-deoxyglycose Positron Emission Tomography (FDG-PET)
Newly diagnosed DLCL patients will have baselne FDG-PET as part of initial staging (PET-1). Patients will then undergo 2 cycles of chemotherapy with R/CHOP. 14 to 21 days following cycle 2 of R/CHOP, patients will undergo repeat FDG-PET scan (PET-2). They will then complete therapy as planned. Following completion of therapy, standard response assessment will be performed, including CT scans of the chest, abdomen and pelvis and FDG-PET scan (PET-3).
- Conditions
- Diffuse Large B-cell Lymphoma
- Keywords
- diffuse large b cell lymphoma, newly diagnosed
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse
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 |
|---|---|---|
| All patients | All patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluating the predictive value of a positive PET scan early in the course of standard chemotherapy
Measured: after 2 cycles of chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2008 (estimated)
- Study startMay 2008
- Primary completionDec 2010
- Study completion8 Dec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Large B-cell LymphomaStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe 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
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rebecca Elstrom, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00754117
- Sponsor's protocol ID
- 0801009588
- Status last verified
- May 2018
- First submitted
- 15 Sep 2008
- Last updated
- 29 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Response Assessment in Patients With Diffuse Large B-cell Lymphoma Using 18-fluoro-2-deoxyglycose Positron Emission Tomography (FDG-PET)
- ClinicalTrials.gov ID
- NCT00754117
- Acronym / sponsor ID
- 0801009588
- Conditions
- Diffuse Large B-cell Lymphoma
- Keywords
- diffuse large b cell lymphoma, newly diagnosed
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- May 2008 (actual)
- Primary completion
- Dec 2010 (actual)
- Study completion
- 8 Dec 2012 (actual)
- First posted
- 17 Sep 2008 (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.
Newly diagnosed DLCL patients will have baselne FDG-PET as part of initial staging (PET-1). Patients will then undergo 2 cycles of chemotherapy with R/CHOP. 14 to 21 days following cycle 2 of R/CHOP, patients will undergo repeat FDG-PET scan (PET-2). They will then complete therapy as planned. Following completion of therapy, standard response assessment will be performed, including CT scans of the chest, abdomen and pelvis and FDG-PET scan (PET-3).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients | – | –All patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Newly diagnosed diffuse large b cell lymphoma patients planning to receive 6-8 cycles of R/CHOP chemotherapy.
Key inclusion criteria (5 listed)
- Patients must have histologically or cytologically confirmed diagnosis of CD20+ diffuse large B cell lymphoma (LBCL) of any stage, including subtypes mediastinal large B cell, centroblastic, immunoblastic, T cell rich B cell and anaplastic B cell lymphoma
- Patients must have received no prior anti-lymphoma therapy.
- Age >18 years.
- Patients must have a treatment plan to include R/CHOP or R/CHOP followed by radiotherapy.
- Ability to understand and the willingness to sign a written informed consent document.
Key exclusion criteria (2 listed)
- Patients who have known HIV infection.
- Patients who are, in the opinion of their treating oncologist, unable to undergo R/CHOP chemotherapy.
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
evaluating the predictive value of a positive PET scan early in the course of standard chemotherapy
Time frame: after 2 cycles of chemotherapy
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 29 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.
Rebecca Elstrom, MD principal investigator
Weill Medical College of Cornell University
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 Diffuse Large B-cell Lymphoma, run by Weill Medical College of Cornell University 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 5 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 29 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 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?
evaluating the predictive value of a positive PET scan early in the course of standard chemotherapy (time frame: after 2 cycles of chemotherapy). 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 29 May 2018.