LymphomaNCT00430053
Clinical Evaluations and Laboratory Studies to Study the Disease Course in Patients With Cutaneous T-Cell Lymphoma
An observational study of Lymphoma, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial summary
RATIONALE: Gathering information about patients with cutaneous T-cell lymphoma over time may help doctors learn more about the disease. PURPOSE: This natural history study is collecting disease-related health information over time from patients with cutaneous T-cell lymphoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma
- What is being tested?
- gene rearrangement analysis, polymerase chain reaction and proteomic profiling
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2004to Jun 2010
- 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
DISEASE CHARACTERISTICS:
- Diagnosis of 1 of the following:
- Histologically confirmed stage IA-IVB cutaneous T-cell lymphoma (CTCL) (mycosis fungoides or Sézary syndrome)
- Other histologically and clinically confirmed primary or secondary CTCL
- Histologically and clinically confirmed pre-CTCL skin condition, including large plaque parapsoriasis and lymphomatoid papulosis
- Measurable disease by skin lesion assessment or Sézary cell count
PATIENT CHARACTERISTICS:
Age
- Over 18
Performance status
- Not specified
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Not specified
Other
- Human T-cell lymphotrophic virus (HTLV) I/II negative
- Not pregnant
- Negative pregnancy test
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Trial locations and contacts
1 site in 1 country.
United States1 site
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
Bethesda, Maryland, 20892-1182
About this study
Official title: Pathogenesis And Course Of Cutaneous T-Cell Lymphoma
RATIONALE: Gathering information about patients with cutaneous T-cell lymphoma over time may help doctors learn more about the disease.
PURPOSE: This natural history study is collecting disease-related health information over time from patients with cutaneous T-cell lymphoma.
Read the detailed description
OBJECTIVES:
Primary
- Follow the disease course of patients with cutaneous T-cell lymphoma.
- Provide a patient population for study by proteomic and molecular analysis.
- Develop a mechanism for screening by a Tumor Board for enrollment of patients in therapeutic clinical trials.
Secondary
- Develop a tissue bank for future disease study using specimens from these patients.
- Provide community outreach by offering a second opinion regarding treatment of this disease in these patients and, in limited cases, provide standard-of-care treatment to these patients.
- Develop an algorithm for screening and evaluating this disease in these patients.
OUTLINE: Patients undergo disease assessment by physical examination, full-body photographic documentation of skin disease, biopsy, and blood sampling at baseline and then at least annually thereafter. Proteomic and molecular methods are used to analyze samples. Biopsies may be examined using histologic and immunohistochemical methods. Blood may be analyzed by polymerase chain reaction for clonal T-cell gene rearrangements or by flow cytometry.
PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study within 5 years.
- Conditions
- Lymphoma
- Being tested
- gene rearrangement analysis, polymerase chain reaction, proteomic profiling, flow cytometry, immunohistochemistry staining method
- Keywords
- stage I cutaneous T-cell non-Hodgkin lymphoma, stage II cutaneous T-cell non-Hodgkin lymphoma, stage III cutaneous T-cell non-Hodgkin lymphoma, stage IV cutaneous T-cell non-Hodgkin lymphoma, stage I mycosis fungoides/Sezary syndrome, stage II mycosis fungoides/Sezary syndrome, stage III mycosis fungoides/Sezary syndrome, stage IV mycosis fungoides/Sezary syndrome
- Medical subject headings
- Lymphoma, Lymphoma, T-Cell, Cutaneous, Mycosis Fungoides, Sezary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gene rearrangement analysisGenetic
polymerase chain reactionGenetic
proteomic profilingGenetic
flow cytometryOther
biopsyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease course of patients with cutaneous T-cell lymphoma (CTCL)
Provide a patient population for study by proteomic and molecular analysis
Mechanism for screening by a Tumor Board for enrollment of patients in therapeutic clinical trials
Secondary outcomes (3)
Develop a tissue bank for future disease study
Offer a second opinion regarding treatment of CTCL and, in limited cases, provide standard-of-care treatment
Develop an algorithm for screening and evaluating CTCL
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2007 (estimated)
- Study startJan 2004
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Mark C. Udey, MD, PhD, Principal investigator, NCI - Dermatology Branch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00430053
- Sponsor's protocol ID
- 040081
- Other IDs
- 04-C-0081, CDR0000354510
- Status last verified
- Mar 2012
- First submitted
- 30 Jan 2007
- Last updated
- 15 Mar 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pathogenesis And Course Of Cutaneous T-Cell Lymphoma
- ClinicalTrials.gov ID
- NCT00430053
- Acronym / sponsor ID
- 040081
- Conditions
- Lymphoma
- Keywords
- stage I cutaneous T-cell non-Hodgkin lymphoma, stage II cutaneous T-cell non-Hodgkin lymphoma, stage III cutaneous T-cell non-Hodgkin lymphoma, stage IV cutaneous T-cell non-Hodgkin lymphoma, stage I mycosis fungoides/Sezary syndrome, stage II mycosis fungoides/Sezary syndrome, stage III mycosis fungoides/Sezary syndrome, stage IV mycosis fungoides/Sezary syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jan 2004
- Study completion
- Jun 2010 (actual)
- First posted
- 1 Feb 2007 (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.
RATIONALE: Gathering information about patients with cutaneous T-cell lymphoma over time may help doctors learn more about the disease.
PURPOSE: This natural history study is collecting disease-related health information over time from patients with cutaneous T-cell lymphoma.
Detailed description
OBJECTIVES:
Primary
- Follow the disease course of patients with cutaneous T-cell lymphoma.
- Provide a patient population for study by proteomic and molecular analysis.
- Develop a mechanism for screening by a Tumor Board for enrollment of patients in therapeutic clinical trials.
Secondary
- Develop a tissue bank for future disease study using specimens from these patients.
- Provide community outreach by offering a second opinion regarding treatment of this disease in these patients and, in limited cases, provide standard-of-care treatment to these patients.
- Develop an algorithm for screening and evaluating this disease in these patients.
OUTLINE: Patients undergo disease assessment by physical examination, full-body photographic documentation of skin disease, biopsy, and blood sampling at baseline and then at least annually thereafter. Proteomic and molecular methods are used to analyze samples. Biopsies may be examined using histologic and immunohistochemical methods. Blood may be analyzed by polymerase chain reaction for clonal T-cell gene rearrangements or by flow cytometry.
PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study within 5 years.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gene rearrangement analysis | Genetic | – |
| polymerase chain reaction | Genetic | – |
| proteomic profiling | Genetic | – |
| flow cytometry | Other | – |
| immunohistochemistry staining method | Other | – |
| biopsy | Procedure or surgery | – |
Primary outcome
Disease course of patients with cutaneous T-cell lymphoma (CTCL)
Provide a patient population for study by proteomic and molecular analysis
Mechanism for screening by a Tumor Board for enrollment of patients in therapeutic clinical trials
3 secondary outcomes
Develop a tissue bank for future disease study
Offer a second opinion regarding treatment of CTCL and, in limited cases, provide standard-of-care treatment
Develop an algorithm for screening and evaluating CTCL
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 15 Mar 2012.
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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.
Mark C. Udey, MD, PhD principal investigator
NCI - Dermatology Branch
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 Lymphoma, run by National Institutes of Health Clinical Center (CC) 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?
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 15 Mar 2012. 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?
Disease course of patients with cutaneous T-cell lymphoma (CTCL). The study lists 3 primary outcomes in all. 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 15 Mar 2012.