NCT03222895 Distribution of Lymph Node Metastases in Esophageal Carcinoma
| NCT ID | NCT03222895 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
| Condition | Esophageal Neoplasms |
| Study Type | OBSERVATIONAL |
| Enrollment | 5,000 participants |
| Start Date | 2019-03-01 |
| Primary Completion | 2025-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 5,000 participants in total. It began in 2019-03-01 with a primary completion date of 2025-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Previous thoracic or abdominal (upper GI) surgery disturbing lymph drainage of the esophagus and stomach * Patients with in situ carcinoma or high grade dysplasia
Contact & Investigator
Suzanne S Gisbertz, MD, PhD
STUDY CHAIR
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Frequently Asked Questions
Who can join the NCT03222895 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Esophageal Neoplasms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03222895 currently recruiting?
Yes, NCT03222895 is actively recruiting participants. Contact the research team at s.s.gisbertz@amc.nl for enrollment information.
Where is the NCT03222895 trial being conducted?
This trial is being conducted at Houston, United States, Rio de Janeiro, Brazil, Toronto, Canada, Shanghai, China and 11 additional locations.
Who is sponsoring the NCT03222895 clinical trial?
NCT03222895 is sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA). The principal investigator is Suzanne S Gisbertz, MD, PhD at Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA). The trial plans to enroll 5,000 participants.