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LymphomaNCT01310933

Ultrasonographic Differentiation Between Kikuchi's Disease and Lymphoma in Patients With Cervical Lymphadenopathy

An observational study of Lymphoma and Kikuchi's Disease, run by Far Eastern Memorial Hospital at 1 site in Taiwan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study is to differentiate Kikuchi's disease and malignant lymphoma by soft tissue ultrasound. Read more about this study

Who is it for?
Ages 3 to 80 years
Conditions the study is for
Lymphoma, Kikuchi's Disease
How many people
40 participants
Where
1 siteTaiwan
Study dates
Dec 2010to Feb 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 3 to 80 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: From November 2007 to September 20010, sonograms of eleven cases notes with pathological diagnoses of Kikuchi's disease and ten patients with malignant lymphoma were studied.

Who may be able to join

  • From November 2007 to September 20010, pathological diagnoses of Kikuchi's disease \& malignant lymphoma were studied sonograms available

Who cannot join

  • no pathology no sonograms

Trial locations and contacts

1 site in 1 country.

Taiwan1 site, 1 recruiting
  • Far Eastern Memorial Hospital, Taipei, Taiwan

    Pan Chiao, Taipei

    Shih-Hong Huang, M.D., Ph.D., 886-8967-1592 ext. 1592, irb@mail.femh.org.tw

    Recruiting

Other trials in Taiwan

About this study

The purpose of this study is to differentiate Kikuchi's disease and malignant lymphoma by soft tissue ultrasound.

Read the detailed description

Introduction Kikuchi's disease (KD) is a histiocytic necrotizing lymphadenitis that was described for the first time in Japan in 1972 almost simultaneously by Kikuchi and Fujimoto1-2. KD is a self-limited necrotizing lymphadenitis and occurs predominantly in females between 20 and 30 years old. Its main presentation is cervical lymphadenopathy. The diagnosis of KD is based on clinical manifestation, fine-needle aspiration cytology or excision biopsy. The pathological characteristics include patchy paracortical lymphohistiocytic aggregates with variable karyorrhexis and absence of granulocytic infiltration. Antibiotics are not helpful symptoms remit within six months spontaneously.

As KD is a benign and self-limiting disease, proper diagnosis may help avoid unnecessary treatment. KD can be easily confused clinically, pathologically, and radiologically with malignant lymphadenopathy, especially lymphoma. Several reports have described the CT characteristics of KD3-4, including enlarged, multiple lymph nodes that are homogeneously enhanced without evidence of gross necrosis. The CT appearance of Kikuchi's disease may be variable, thus mimicking lymphoma4. In previous work, the ultrasound appearance of KD has not been well-described and has been compared to lymphoma. In this study, we compared the sonographic characteristic of Kikuchi's disease and malignant lymphoma.

Patients and methods From November 2007 to September 2009, sonograms of twelve case notes with pathological diagnoses of Kikuchi's disease and twelve patients with malignant lymphoma were studied.

The sonograms were performed by the same sinologist (L-J Liao) using an ATL HDI 5000 with a high-resolution 7.5- to 12-MHz real-time linear-array transducer (Philips Ultrasound, Bothell, WA, USA). Morphological US parameters were thoroughly evaluated and recorded on the Marosis PACS system (Marotech Inc., Seoul, South Korea). The lengths of short and long axes of enlarged lymph nodes were measured and recorded. The shape of the lymph node was determined by the short axis to long axis ratio (S/L ratio). The nodal border was assessed for sharpness. Echogenicity of the lymph nodes was compared with that of adjacent muscles. Swelling of the surrounding tissues that presented with hyperechoic rims was assessed. The nodes were considered matted when a number of lymph nodes were clustered together. The internal architecture of lymph nodes was examined for the presence of heterogeneous micronodular pattern or reticulation.

Fisher's exact test and X 2 test were used to calculate the significance of the difference in gray-scale features. Mann-Whitney U tests were used to calculate the significance of the difference in nodal size and short- to long-axis ratio.

Expected Results:

We suppose that basic ultrasonographic characteristics (size, shape, rims, matting, and micronodular echotexture) help in the differentiation of cervical lymph nodes in patients with Kikuchi's disease and lymphoma. A precise diagnosis of KD is possible avoiding unnecessary biopsies or aggressive treatment.

References:

  1. Kikuchi M. Lymphadenitis showing focal reticulum cell hyperplasia with nuclear debris and phagocytosis. Nippon Ketsueki Kakkai Zasshi 1972;35:379-80.
  2. Fujimoto Y, Kozima Y, Yamaguchi K. Cervical subacute necrotizing lymphadenitis. A new clinicological entity. Naika 1972;376:247-53.
  3. Kwon S, Kim T, Kim Y, Lee K, Lee N, Seol H. CT findings in Kikuchi disease: analysis of 96 cases. American Journal of Neuroradiology 2004;25(6):1099.
  4. Na D, Chung T, Byun H, Kim H, Ko Y, Yoon J. Kikuchi disease: CT and MR findings. American Journal of Neuroradiology 1997;18(9):1729.
Medical subject headings
Lymphoma, Histiocytic Necrotizing Lymphadenitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01310933
Study groupRoleWhat they receive
Kikuchi's diseaseNot described
Malignant lymphomaNot described

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Mar 2011 (estimated)
  2. Study startDec 2010
  3. Study completionFeb 2012 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Time perspective
Retrospective
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01310933
Sponsor's protocol ID
099086-E
Status last verified
Jan 2012
First submitted
21 Feb 2011
Last updated
2 Feb 2012
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Lymphoma and Kikuchi's Disease, run by Far Eastern Memorial Hospital at 1 site in Taiwan.

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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 2 Feb 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 Taiwan. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Li-Jen Liao, MD (886-2-89667000 ext. 4201, deniro@mail2000.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.

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 2 Feb 2012.

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