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Establishing a Tumor Registry for Patients With Neuroendocrine Carcinoma of the Cervix

Establishing a Tumor Registry for Patients With Neuroendocrine Carcinoma of the Cervix

Recruiting
All
Phase N/A

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Overview

This study collects information and data on patients with neuroendocrine cervical cancer. Information from this study may be used to better understand the correlation between clinical data, such as patient characteristics, treatment, and disease outcomes, and overall patient outcomes.

Description

PRIMARY OBJECTIVES:

I. To collect, both prospectively and retrospectively, data on disease characterization, treatment, and outcomes for patients with neuroendocrine carcinoma of the uterine cervix.

II. To organize clinical information in order to support multifaceted queries of patient characteristics, treatment, and disease outcome data and to facilitate correlation of these characteristics with patient outcome.

III. To have a single data repository kept on a secure platform that will integrate clinical information and research findings and serve as an archive for future research.

OUTLINE

Patients' medical records are reviewed retrospectively and prospectively. Patients are followed up by email, telephone, or United States (U.S.) mail every 4 months for up to 10 years from date of initial study enrollment. Patients, who are beyond 5 years from their initial diagnosis, are followed up by email, telephone, or U.S. mail annually.

Eligibility

Inclusion Criteria:

  • Patients with a personal history of cervical cancer with any portion of neuroendocrine component (including mixed tumors) of the following histologic subtypes:
    • Small cell neuroendocrine carcinoma
    • Large cell neuroendocrine carcinoma
    • Undifferentiated high-grade neuroendocrine carcinoma
  • Patients may be in any stage of treatment, surveillance or recurrence at the time of

    initial participation in the study

  • Patients with all stages of disease are considered eligible
  • Patients who do not speak English can be eligible if accompanied by an institutional interpreter
  • Patients who are receiving or have received treatment at any facility, including but not limited to M. D. Anderson Cancer Center are eligible
  • Patient may be residents of any country and be of any ethnic background
  • Patients who request to participate in the study, regardless of the method by which they learned of it, are eligible to participate, including, but not limited to patients who seek participation via the website
  • Next of kin or legal authorized representatives of patients who are deceased but had a history of neuroendocrine carcinoma (NEC) of the cervix are eligible to participate
  • Next of kin or legal authorized representatives of patients must read and speak English

Exclusion Criteria:

  • Patients with other histologic subtypes of NEC of the cervix including typical and atypical carcinoid tumors

Study details
    Cervical Large Cell Neuroendocrine Carcinoma
    Cervical Neuroendocrine Carcinoma
    Cervical Small Cell Carcinoma
    Cervical Undifferentiated Carcinoma
    Stage I Cervical Cancer AJCC v8
    Stage IA Cervical Cancer AJCC v8
    Stage IA1 Cervical Cancer AJCC v8
    Stage IA2 Cervical Cancer AJCC v8
    Stage IB Cervical Cancer AJCC v8
    Stage IB1 Cervical Cancer AJCC v8
    Stage IB2 Cervical Cancer AJCC v8
    Stage II Cervical Cancer AJCC v8
    Stage IIA Cervical Cancer AJCC v8
    Stage IIA1 Cervical Cancer AJCC v8
    Stage IIA2 Cervical Cancer AJCC v8
    Stage IIB Cervical Cancer AJCC v8
    Stage III Cervical Cancer AJCC v8
    Stage IIIA Cervical Cancer AJCC v8
    Stage IIIB Cervical Cancer AJCC v8
    Stage IV Cervical Cancer AJCC v8
    Stage IVA Cervical Cancer AJCC v8
    Stage IVB Cervical Cancer AJCC v8

NCT04723095

M.D. Anderson Cancer Center

21 February 2024

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