NCT03719833Befejeződött
Sentinel Lymph Node Biopsy After Neoadjuvant Treatment in Breast Cancer Patents
Sentinel Lymph Node Biopsy After Neoadjuvant Oncological Treatment in Luminal B, HER-2 Positive and Triple Negative Breast Cancer Patients in Stage T1-3 N0-2 M0 at the Time of Diagnose
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. júl. 30.
Rövid összefoglaló (regiszter, angolul)
This clinical trial is designed as an observational study of 8-9 years of overall duration, but the first results and conclusions could be achieved in 3-4 years. In the first phase, which would last 3-4 years, the investigators will form three predetermined groups of breast cancer patients that would be monitored in the second phase for 5 postoperative years. All patients involved in this trial would undergo a defined protocol. All patients participating in this trial and all members of the investigation team would be completely introduced to the plan and aims of this trial. Two main hypotheses of this trial are that SLNB does not have a negative impact on clinical outcomes (locoregional recurrence and overall survival) in initially node-positive patients who achieved complete clinically axillary remission after neoadjuvant systemic treatment and that lymph node status after neoadjuvant treatment is a significantly more relevant prognostic factor than nodal status at the time of diagnosis. Therefore, the aim is to establish that sentinel lymph node biopsy, in node-positive breast cancer patients that achieve clinical remission after neoadjuvant treatment, is a reliable approach for surgical axillary management. Data would be collected individually for each patient and recorded on appropriate forms. After data completion, the principal investigator would import encoded data into the register. Data collected in this trial would be used for publications.
- Állapot (regiszter)
- Befejeződött
- Vizsgálattípus
- Megfigyeléses
- Résztvevők száma
- 230 (tényleges)
- Első benyújtás
- 2018. okt. 23.
- Kezdés
- 2018. szept. 21.
- Elsődleges befejezés
- 2025. júl. 28.
- Fő szponzor
- Clinical Hospital Center Rijeka
- Betegségek
- Tripla negatív emlőrák
- NCT-szám
- NCT03719833
Mit vállalsz
- Vizsgálat típusa: Megfigyeléses
- Bevont résztvevők: 230
- 2018. szept. 21. és az elsődleges befejezés (2025. júl. 28.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Korábbi kezelés
- Patients that have had previously SLNB or ALND or radiotherapy to the axillary nodes
Más betegség
- Patients with bilateral disease
- Patients that have been or are treated for other malignant disease
- Patients with hypersensitivity or allergy to radiocolloid
- Psychiatric patients
Egyéb
- Patents in T4 stage and/or N3 stage and/or M1 stage at the time of diagnosis
- Patients with inflammatory carcinoma
- Patients with ipsilateral recurrence
- Patients with histological type-lobular and immunophenotype-Luminal A
- Patients that are not eligible for oncological treatment according to protocol, either neoadjuvant or adjuvant, or oncological treatment was interrupted (aborted or completed in another institution)
- Patients without complete documentation required for this study
- Pregnant patients
- Male patients
Kiket keres a vizsgálat
- Patients must be female
- Patients must be older than 18 years of age and younger than 80 years of age
- Patients must have biopsy-proven breast cancer, histological type-ductal, immunophenotype-Luminal B, HER-2 positive and triple-negative
- Patients with nodal disease (N1-N2) must have fine needle aspiration proven positive node and marked node with titanium clip before onset of neoadjuvant treatment
- Patients treated (oncological and surgical) in Clinical Hospital Centar Rijeka from September 2018 till May 2022
- Patients must be in stage cT1-3 cN0-2 cM0 at the time of diagnosis and cN0 at the time of the surgery
- Patients that are eligible for neoadjuvant oncological treatment, accepting to undergo it and complete it
- Patients who understand, accept and have signed the approved consent form
Életkor a regiszterben: 18 év – 80 év · Nem: csak nők · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Ana Car Peterko | Rijeka | Horvátország | Ismeretlen állapot |
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