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)
- Diseases
- Gastric and esophageal cancer
- 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
Sites (19)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Instituto Nacional de Câncer Coordinator of this site? Confirm its status | Rio de Janeiro | Brazil | Recruiting |
| University of Toronto Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
| Fudan University Shanghai Cancer Center Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| University Medical Center of the Johannes Gutenberg University Coordinator of this site? Confirm its status | Mainz | Germany | Recruiting |
| Hospital Universitario del Mar Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital District of Helsinki and Uusimaa Coordinator of this site? Confirm its status | Helsinki | Finland | Recruiting |
| University of Athens, School of Medicine Coordinator of this site? Confirm its status | Athens | Greece | Recruiting |
| University of Hong Kong Coordinator of this site? Confirm its status | Hong Kong | Hong Kong SAR China | Recruiting |
| Tata Memorial Centre Coordinator of this site? Confirm its status | Mumbai | India | Recruiting |
| Ospedale San Raffaele Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| IRCCS Policlinico San donato Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| University of Verona Coordinator of this site? Confirm its status | Verona | Italy | Recruiting |
| Uonuma Institute and Niigata University Coordinator of this site? Confirm its status | Niigata | Japan | Recruiting |
| The Cancer Institute Hospital of JFCR Coordinator of this site? Confirm its status | Tokyo | Japan | Recruiting |
| Keio University School of Medicine Coordinator of this site? Confirm its status | Tokyo | Japan | Recruiting |
| Ziekenhuisgroep Twente, Almelo & Hengelo Coordinator of this site? Confirm its status | Almelo | Netherlands | Recruiting |
| Amsterdam UMC Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Recruiting |
| Karolinska Institutet Coordinator of this site? Confirm its status | Stockholm | Sweden | Recruiting |
| MD Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.