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Distribution of Lymph Node Metastases in Esophageal Carcinoma
NCT03222895 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Study Locations (19)
Other
- Instituto Nacional de Câncer — Rio de Janeiro
- University of Toronto — Toronto
- Hospital District of Helsinki and Uusimaa — Helsinki
- University Medical Center of the Johannes Gutenberg University — Mainz
- University of Athens, School of Medicine — Athens
- University of Hong Kong — Hong Kong
- Tata Memorial Centre — Mumbai
- IRCCS Policlinico San Donato — Milan
- Ospedale San Raffaele — Milan
- University of Verona — Verona
- Uonuma Institute and Niigata University — Niigata
- Keio University School of Medicine — Tokyo
- The Cancer Institute Hospital of JFCR — Tokyo
- Ziekenhuisgroep Twente, Almelo & Hengelo — Almelo
- Amsterdam UMC — Amsterdam
- Hospital Universitario del Mar — Barcelona
- Karolinska Institutet — Stockholm
Texas
- MD Anderson Cancer Center — Houston
Yangpu
- Fudan University Shanghai Cancer Center — Shanghai
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5,000 participants |
| Start Date | 2019-03-01 |
| Est. Completion | 2028-06-01 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03222895
The ClinicalTrials.gov registry entry for NCT03222895 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 5,000 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), which has 33 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Esophageal Neoplasms appearing as the primary indexed condition, and to 0 interventions. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03222895 reports 19 study locations spanning 3 distinct geographic areas — top geographies include Other, Texas, Yangpu. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03222895 about?
NCT03222895 is a clinical study titled "Distribution of Lymph Node Metastases in Esophageal Carcinoma". 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 di...
What is the current status of trial NCT03222895?
This trial is currently recruiting. The enrollment target is 5,000 participants. The study started on 2019-03-01. Estimated completion is 2028-06-01.
What conditions does trial NCT03222895 study?
This clinical trial studies the following conditions: Esophageal Neoplasms, Lymph Node Metastases. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
Who is sponsoring clinical trial NCT03222895?
This trial is sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), which has 33 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03222895 being conducted?
This trial has 19 study locations across Texas, Yangpu. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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