Condition category
Cancer
Date applied
23/03/2011
Date assigned
04/05/2011
Last edited
03/04/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Goran Marjanovic

ORCID ID

Contact details

Klinika za hematologiju i kliničku imunologiju
Klinički Centar Niš
Bulevar Dr. Zorana Đinđića 48
Niš
18000
Serbia

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Palpable Lymphadenopathy In Clinical Practice: a multi-centre, prospective, case-control study

Acronym

PLICP

Study hypothesis

In adult patients with palpable lymphadenopathy are there any clinical or ultrasound factors indicative of malignancy? What is the correlation between those factors? How sensitive and specific are they in comparison to the pathologic examination of the biopsied lymph node for establishing a diagnosis of malignancy?

The rationale behind this study is that malignant and benign lymphadenopathies have specific quantifiable identifiers. We hope that we will find and quantify signs form clinical and ultrasound examination of the patients with limphadenopathies that would point to a malignant or benign cause of the lymphadenopathy. The main purpose for this study is to shorten the average time to diagnosis for patients with lymphadenopathy and to ascertain whether
inexpensive route to the diagnosis. This study should yield a decision making algorithm for palpable lymphadenopathies. This study will attempt to map the spread of tumors from different regions to their regional lymph nodes.

As of 27/03/2012, the anticipated end date of trial has been updated from 01/04/2012 to 01/04/2013.

As of 03/04/2013, the anticipated end date of trial has been updated from 01/04/2013 to 01/04/2014.

Ethics approval

The study was approved by the Clinical Center Nish Ethics Board on 01/02/2011 ref: approval number 2280/32

Study design

Multi-centre prospective case-control study

Primary study design

Observational

Secondary study design

Case-control study

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Palpable lymph node enlargement

Intervention

1. This is an observational study and all interventions are decided upon by the patients physician and are not influenced by the study design.
2. This study will collect data from clinical, ultrasound and intraoperative examination of the patient and his enlarged lymph nodes
3. This study also collects data from the pathologic examination of the biopsied lymph node
4. The data regarding the lymphadenopathy will be collected by the patients physicians during the time of the exam and inputed in pre-made forms which will then be stored in databases for statistical testing at the end of the study
5. The two primary arms will be benign and malignant palpable lymphadenopathy
6. Secondary (optional) arms are non-palpable but peripheral lymphadenopathies obtained from:
6.1. Incidental radiologic findings
6.2. Planned sentinel node biopsies
6.3. Planned region dissections for primary disease staging
7. For the purpose of this study peripheral lymph nodes are:
7.1. Submandibular,
7.2. Submental
7.3. Preauricular
7.4. Retroauricular
7.5. Occipita
7.6. Upper, middle and lower jugular
7.7. Prelaringeal
7.8. Posterocervical
7.9. Suboccipital
7.10. Supraclavicular
7.11. Infraclavicular
7.12. Middle and lower axillary
7.13. Epitrochlear
7.14. Surface inguinal
7.15. Deep inguinal
7.16. Popliteal
8. The primary analysis will attempt to find clinical and ultrasound parameters correlating with a pathologic diagnosis of malignancy and those correlating with a benign cause
9. The statistician will decide on the statistical methods that will be used when the study ends and the database is reviewed

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Determining the correlation between the parameters collected in our study through clinical and ultrasound examination with the:
1. Diagnosis of malignancy established by pathologic examination of the biopsied lymph node
2. Diagnosis of a benign disease established by pathologic examination of the biopsied lymph node
3. Diagnosis of a benign cause of lymphadenopathy established by spontaneous reversal of lymphadenopathy sustained over 3 months
4. The parameters collected are:
4.1. Clinical exam and history: age, sex
4.2. Node location and external size (2 dimensions)
4.3. Presence of splenomegaly
4.4. Pain on palpation
4.5. Lymph node texture (subjective)
4.6. Complete blood count (CBC)
4.7. Lactate dehydrogenase (LDH)
4.8. Erythrocyte sedimentation
4.9. Presence of night sweats
4.10. Pruritus
4.11. Unexplained loss of weight, or unexplained fevers
4.12. History of malignant diseases
4.13. Presence of any "supicious" lesion during a whole body physicial exam
5. Ultrasound:
5.1. Size, location and number of enlarged lymph nodes, echogenicity (hyper, hypo, hilar, diffuse, perinodal, localised)
5.2. Demarcation from surrounding tissue
5.3. Presence of necrosis
5.4. Vascularity (avascular, hillar, diffuse, peripheral, localised)
5.5. Calcifications
5.6. Presence of splenomegaly
5.7. Resistive and pulsatile index
6. Pathologic examination:
6.1. Size of lymph node
6.2. Microscopic morphology (normal-resembles lymph node, changed does not resemble a lymph node)
6.3. Presence of granulomas, necrosis or calcifications
6.4. Presence of metastasis and size
6.5. Final diagnosis

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/04/2011

Overall trial end date

01/04/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients with palpable lymphadenopathy
2. Patients with radiologically proven, but still not palpable, peripheral lymphadenopathy
3. Patients with a sentinel node biopsy or regional dissections as part of their staging

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Minimum number: 100 malignant and 100 benign

Participant exclusion criteria

1. Patients unable or unwilling to give consent
2. Patients younger than 18

Recruitment start date

01/04/2011

Recruitment end date

01/04/2014

Locations

Countries of recruitment

Serbia

Trial participating centre

Klinika za hematologiju i kliničku imunologiju
Niš
18000
Serbia

Sponsor information

Organisation

Serbian Medical Society (SLD Niš, gradska podružnica) (Serbia)

Sponsor details

Bulevar Zorana Đinđića 50
Nish
18000
Serbia

Sponsor type

Other

Website

http://www.sldnis.org.rs/

Funders

Funder type

Research organisation

Funder name

Serbian Medical Society (Srpsko Lekarsko Društvo) (Serbia)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes