Sign in

NCT03222895Recruiting

Distribution of Lymph Node Metastases in Esophageal Carcinoma

Source: ClinicalTrials.gov · Last updated 13 Feb 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

Background: Lymph node status is an important prognostic parameter in esophageal carcinoma and an independent predictor of survival. Distribution of metastatic lymph nodes may vary with tumor location, tumor histology, tumor invasion depth and neoadjuvant therapy. Surgical strategy depends on the distribution pattern of nodal metastases but consensus on the extent of lymphadenectomy differs worldwide. Especially for adenocarcinoma the distribution of lymph node metastases has not yet been described in large series. Aim of the present study is to evaluate the distribution of lymph node metastases in esophageal carcinoma specimens following transthoracic esophagectomy with at least a 2-field lymphadenectomy. Methods: The TIGER-study is a multinational observational cohort study. All patients with a resectable esophageal or gastro-esophageal junction carcinoma in whom a transthoracic esophagectomy with a 2- or 3-field lymphadenectomy is performed in participating centers will be included. All lymph node stations will be excised and separately sent for pathological examination. Cluster analysis will be performed to identify patterns of metastases in relation to tumor location, tumor histology, tumor invasion depth and neoadjuvant therapy. Conclusion: TIGER will provide a roadmap of the location of lymph node metastases in relation to tumor histology, tumor location, invasion depth, number of lymph nodes and lymph node metastases, pre-operative diagnostics, neo-adjuvant therapy and survival. Patient-tailored treatment can be developed on the basis of these results, such as the the optimal radiation field and extent of lymphadenectomy based on the primary tumor characteristics.

Status (registry)
Recruiting
Study type
Observational
Enrollment
5000 (estimated)
First submitted
17 Jul 2017
Start date
1 Mar 2019
Primary completion date
1 Jan 2025
Lead sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
NCT number
NCT03222895

What you commit to

  • Study type: Observational
  • Planned participants: 5000
  • From 1 Mar 2019 to the primary completion date, 1 Jan 2025
  • 19 sites in 14 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous thoracic or abdominal (upper GI) surgery disturbing lymph drainage of the esophagus and stomach

Other

  • Patients with in situ carcinoma or high grade dysplasia

Who the study is looking for

  • Primary squamous cell or adenocarcinoma of the esophagus or esophago-gastric junction
  • Surgically resectable (cT1-4a, N0-3, M0)
  • Adequate physical condition to undergo transthoracic surgery (ASA 1-3)
  • Transthoracic esophagectomy

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (19)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Instituto Nacional de Câncer
Coordinator of this site? Confirm its status
Rio de JaneiroBrazilRecruiting
University of Toronto
Coordinator of this site? Confirm its status
TorontoCanadaRecruiting
Fudan University Shanghai Cancer Center
Coordinator of this site? Confirm its status
ShanghaiChinaRecruiting
University Medical Center of the Johannes Gutenberg University
Coordinator of this site? Confirm its status
MainzGermanyRecruiting
Hospital Universitario del Mar
Coordinator of this site? Confirm its status
BarcelonaSpainRecruiting
Hospital District of Helsinki and Uusimaa
Coordinator of this site? Confirm its status
HelsinkiFinlandRecruiting
University of Athens, School of Medicine
Coordinator of this site? Confirm its status
AthensGreeceRecruiting
University of Hong Kong
Coordinator of this site? Confirm its status
Hong KongHong Kong SAR ChinaRecruiting
Tata Memorial Centre
Coordinator of this site? Confirm its status
MumbaiIndiaRecruiting
Ospedale San Raffaele
Coordinator of this site? Confirm its status
MilanItalyRecruiting
IRCCS Policlinico San donato
Coordinator of this site? Confirm its status
MilanItalyRecruiting
University of Verona
Coordinator of this site? Confirm its status
VeronaItalyRecruiting
Uonuma Institute and Niigata University
Coordinator of this site? Confirm its status
NiigataJapanRecruiting
The Cancer Institute Hospital of JFCR
Coordinator of this site? Confirm its status
TokyoJapanRecruiting
Keio University School of Medicine
Coordinator of this site? Confirm its status
TokyoJapanRecruiting
Ziekenhuisgroep Twente, Almelo & Hengelo
Coordinator of this site? Confirm its status
AlmeloNetherlandsRecruiting
Amsterdam UMC
Coordinator of this site? Confirm its status
AmsterdamNetherlandsRecruiting
Karolinska Institutet
Coordinator of this site? Confirm its status
StockholmSwedenRecruiting
MD Anderson Cancer Center
Coordinator of this site? Confirm its status
HoustonUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.