LymphomaNCT00066664
Serum Protein Patterns in Participants With Mycosis Fungoides/Cutaneous T-Cell Lymphoma, Psoriasis, or Normal Skin
A study testing proteomic profiling in people with Lymphoma, run by National Institutes of Health Clinical Center (CC) at 4 sites in United States.
Trial summary
RATIONALE: The presence of specific serum proteins may allow a doctor to determine if a patient has mycosis fungoides/cutaneous T-cell lymphoma. PURPOSE: This clinical trial is studying how well blood protein analysis detects mycosis fungoides/cutaneous T-cell lymphoma. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Lymphoma
- What is being tested?
- proteomic profiling
- How many people
- 423 participants
- Where
- 4 sitesUnited States
- Study dates
- Jun 2003to Mar 2010
- Phase
- Interventional
- 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 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Meets criteria for 1 of the following categories:
- Healthy skin volunteer
- No significant inflammatory or neoplastic disease of the skin or internal organs
- Diagnosis of 1 of the following skin diseases*:
- Psoriasis
- Plaque-type disease
- Psoriasis Area and Severity Index score at least 12
- Mycosis fungoides/cutaneous T-cell lymphoma
- Clinical diagnosis of T1-T4 skin disease with a compatible pathologic diagnosis NOTE: *Stable or worsening disease on no therapy or topical therapy only within the past 2 weeks
PATIENT CHARACTERISTICS:
Age
- 18 to 85
Performance status
- Not specified
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Not specified
Other
- Not pregnant
- No known HIV-1-related diseases
- No known HTLV-1-related diseases
- Willing to undergo brief skin examination and fill out a questionnaire regarding skin and general health
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Other
- More than 2 weeks since prior systemic therapy for skin disease
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109-0942
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231-2410
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
Bethesda, Maryland, 20892-1182
Stanford Cancer Center
Stanford, California, 94305-5824
About this study
Official title: Characterization of Serum Proteomic Patterns in Neoplastic and Inflammatory Skin Disease
RATIONALE: The presence of specific serum proteins may allow a doctor to determine if a patient has mycosis fungoides/cutaneous T-cell lymphoma.
PURPOSE: This clinical trial is studying how well blood protein analysis detects mycosis fungoides/cutaneous T-cell lymphoma.
Read the detailed description
OBJECTIVES:
- Determine whether computer-assisted, higher-order analysis of participant low molecular weight serum proteins can detect distinctive proteomic patterns in participants with normal skin vs mycosis fungoides/cutaneous T-cell lymphoma vs psoriasis.
- Determine whether these proteomic patterns can distinguish between various stages of cutaneous T-cell lymphoma.
OUTLINE: This is a pilot study.
Participants complete a general and skin health questionnaire and undergo a whole-body skin examination. Blood samples are taken and analyzed for low molecular weight serum proteins by mass spectroscopy.
PROJECTED ACCRUAL: A total of 141-423 participants (47-94 each of healthy volunteers, psoriasis patients, and T3 cutaneous T-cell lymphoma patients and 141 T1, T2, and T4 mycosis fungoides patients) will be accrued for this study within 3 years.
- Conditions
- Lymphoma
- Being tested
- proteomic profiling
- Keywords
- recurrent cutaneous T-cell non-Hodgkin lymphoma, 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, recurrent mycosis fungoides/Sezary syndrome, 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.
proteomic profilingGenetic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2003 (estimated)
- Study startJun 2003
- Primary completionDec 2007
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Enrolment
- 423 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
- NCT00066664
- Sponsor's protocol ID
- 030228
- Other IDs
- 03-C-0228, CDR0000316453
- Status last verified
- Mar 2012
- First submitted
- 6 Aug 2003
- Last updated
- 15 Mar 2012
- Results posted
- No
Publications
Liu C, Shea N, Rucker S, Harvey L, Russo P, Saul R, Lopez MF, Mikulskis A, Kuzdzal S, Golenko E, Fishman D, Vonderheid E, Booher S, Cowen EW, Hwang ST, Whiteley GR. Proteomic patterns for classification of ovarian cancer and CTCL serum samples utilizing peak pairs indicative of post-translational modifications. Proteomics. 2007 Nov;7(22):4045-52. doi: 10.1002/pmic.200601044.
PubMed 17952875Cowen EW, Liu CW, Steinberg SM, Kang S, Vonderheid EC, Kwak HS, Booher S, Petricoin EF, Liotta LA, Whiteley G, Hwang ST. Differentiation of tumour-stage mycosis fungoides, psoriasis vulgaris and normal controls in a pilot study using serum proteomic analysis. Br J Dermatol. 2007 Nov;157(5):946-53. doi: 10.1111/j.1365-2133.2007.08185.x. Epub 2007 Sep 13.
PubMed 17854367
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
- Characterization of Serum Proteomic Patterns in Neoplastic and Inflammatory Skin Disease
- ClinicalTrials.gov ID
- NCT00066664
- Acronym / sponsor ID
- 030228
- Conditions
- Lymphoma
- Keywords
- recurrent cutaneous T-cell non-Hodgkin lymphoma, 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, recurrent mycosis fungoides/Sezary syndrome, stage I mycosis fungoides/Sezary syndrome, stage II mycosis fungoides/Sezary syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 423 participants (estimated)
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jun 2003
- Primary completion
- Dec 2007 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 7 Aug 2003 (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: The presence of specific serum proteins may allow a doctor to determine if a patient has mycosis fungoides/cutaneous T-cell lymphoma.
PURPOSE: This clinical trial is studying how well blood protein analysis detects mycosis fungoides/cutaneous T-cell lymphoma.
Detailed description
OBJECTIVES:
- Determine whether computer-assisted, higher-order analysis of participant low molecular weight serum proteins can detect distinctive proteomic patterns in participants with normal skin vs mycosis fungoides/cutaneous T-cell lymphoma vs psoriasis.
- Determine whether these proteomic patterns can distinguish between various stages of cutaneous T-cell lymphoma.
OUTLINE: This is a pilot study.
Participants complete a general and skin health questionnaire and undergo a whole-body skin examination. Blood samples are taken and analyzed for low molecular weight serum proteins by mass spectroscopy.
PROJECTED ACCRUAL: A total of 141-423 participants (47-94 each of healthy volunteers, psoriasis patients, and T3 cutaneous T-cell lymphoma patients and 141 T1, T2, and T4 mycosis fungoides patients) will be accrued for this study within 3 years.
Study design
- Primary purpose
- Diagnosis
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- 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 |
|---|---|---|
| proteomic profiling | Genetic | – |
Primary outcome
Not reported in the source record.
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.
- Background: PubMed 17952875Liu C, Shea N, Rucker S, Harvey L, Russo P, Saul R, Lopez MF, Mikulskis A, Kuzdzal S, Golenko E, Fishman D, Vonderheid E, Booher S, Cowen EW, Hwang ST, Whiteley GR. Proteomic patterns for classification of ovarian cancer and CTCL serum samples utilizing peak pairs indicative of post-translational modifications. Proteomics. 2007 Nov;7(22):4045-52. doi: 10.1002/pmic.200601044.
- Results publication: PubMed 17854367Cowen EW, Liu CW, Steinberg SM, Kang S, Vonderheid EC, Kwak HS, Booher S, Petricoin EF, Liotta LA, Whiteley G, Hwang ST. Differentiation of tumour-stage mycosis fungoides, psoriasis vulgaris and normal controls in a pilot study using serum proteomic analysis. Br J Dermatol. 2007 Nov;157(5):946-53. doi: 10.1111/j.1365-2133.2007.08185.x. Epub 2007 Sep 13.
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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
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing proteomic profiling in people with Lymphoma, run by National Institutes of Health Clinical Center (CC) at 4 sites 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 4 sites 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00066664, which also lists 2 linked publications.
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.