Palpable Lymphadenopathy In Clinical Practice
| ISRCTN | ISRCTN99581977 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN99581977 |
| Secondary identifying numbers | N/A |
- Submission date
- 23/03/2011
- Registration date
- 04/05/2011
- Last edited
- 03/04/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Goran Marjanovic
Scientific
Scientific
Klinika za hematologiju i kliničku imunologiju
Klinički Centar Ni
Bulevar Dr. Zorana Đinđića 48
Ni
18000
Serbia
Study information
| Study design | Multi-centre prospective case-control study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Case-control study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Palpable Lymphadenopathy In Clinical Practice: a multi-centre, prospective, case-control study |
| Study acronym | PLICP |
| Study objectives | 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(s) | The study was approved by the Clinical Center Nish Ethics Board on 01/02/2011 ref: approval number 2280/32 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/04/2011 |
| Completion date | 01/04/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Minimum number: 100 malignant and 100 benign |
| Key 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 |
| Key exclusion criteria | 1. Patients unable or unwilling to give consent 2. Patients younger than 18 |
| Date of first enrolment | 01/04/2011 |
| Date of final enrolment | 01/04/2014 |
Locations
Countries of recruitment
- Serbia
Study participating centre
Klinika za hematologiju i kliničku imunologiju
Ni
18000
Serbia
18000
Serbia
Sponsor information
Serbian Medical Society (SLD Ni, gradska podrunica) (Serbia)
Other
Other
Bulevar Zorana Đinđića 50
Nish
18000
Serbia
| Website | http://www.sldnis.org.rs/ |
|---|
Funders
Funder type
Research organisation
Serbian Medical Society (Srpsko Lekarsko Drutvo) (Serbia)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
