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.
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
- 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
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:
- Kikuchi M. Lymphadenitis showing focal reticulum cell hyperplasia with nuclear debris and phagocytosis. Nippon Ketsueki Kakkai Zasshi 1972;35:379-80.
- Fujimoto Y, Kozima Y, Yamaguchi K. Cervical subacute necrotizing lymphadenitis. A new clinicological entity. Naika 1972;376:247-53.
- 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.
- 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.
- Conditions
- Lymphoma, Kikuchi's Disease
- 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 group | Role | What they receive |
|---|---|---|
| Kikuchi's disease | Not described | |
| Malignant lymphoma | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2011 (estimated)
- Study startDec 2010
- Study completionFeb 2012 (estimated)
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
- Time perspective
- Retrospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li-Jen Liao, Far Eastern Memorial Hospital
- Investigators
- Li-Jen Liao, MD, Study chair, Department of Otolaryngology Far Eastern Memorial Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasonographic Differentiation Between Kikuchi's Disease and Lymphoma in Patients With Cervical Lymphadenopathy
- ClinicalTrials.gov ID
- NCT01310933
- Acronym / sponsor ID
- 099086-E
- Conditions
- Lymphoma, Kikuchi's Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Study start
- Dec 2010
- Study completion
- Feb 2012 (estimated)
- First posted
- 9 Mar 2011 (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 differentiate Kikuchi's disease and malignant lymphoma by soft tissue ultrasound.
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:
- Kikuchi M. Lymphadenitis showing focal reticulum cell hyperplasia with nuclear debris and phagocytosis. Nippon Ketsueki Kakkai Zasshi 1972;35:379-80.
- Fujimoto Y, Kozima Y, Yamaguchi K. Cervical subacute necrotizing lymphadenitis. A new clinicological entity. Naika 1972;376:247-53.
- 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.
- 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.
Study design
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kikuchi's disease | – | – |
| Malignant lymphoma | – | – |
Who may qualify
- Ages
- 3 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (1 listed)
- From November 2007 to September 20010, pathological diagnoses of Kikuchi's disease \& malignant lymphoma were studied sonograms available
Key exclusion criteria (1 listed)
- no pathology no sonograms
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 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.
Li-Jen Liao, MD study chair
Department of Otolaryngology Far Eastern Memorial Hospital
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 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.