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

February 12, 2024 updated by: M.D. Anderson Cancer Center
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Estimated)

750

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • M D Anderson Cancer Center
        • Contact:
        • Principal Investigator:
          • Michael M. Frumovitz, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with neuroendocrine cervical cancer

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Observational (medical chart review)
Patients' medical records are reviewed retrospectively and prospectively. Patients are followed up by email, telephone, or 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.
Other: Medical Chart Review
Review of medical records
Other Names:
  • Chart Review
Other: Follow-Up
Receive follow up
Other Names:
  • Active Follow-up
  • Clinical Signs Follow-up
  • CLSFUP
  • Follow Up
  • Followed
  • Followup

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease characterization data
Time Frame: through study completion, an average of 1 year
Information collected from retrospective and prospective review of medical records.
through study completion, an average of 1 year
Patient treatment data
Time Frame: through study completion, an average of 1 year
Information collected from retrospective and prospective review of medical records.
through study completion, an average of 1 year
Patient outcome data
Time Frame: through study completion, an average of 1 year
Information collected from retrospective and prospective review of medical records.
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Investigators

  • Principal Investigator: Michael M Frumovitz, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 16, 2013

Primary Completion (Estimated)

January 1, 2044

Study Completion (Estimated)

January 1, 2044

Study Registration Dates

First Submitted

October 13, 2020

First Submitted That Met QC Criteria

January 21, 2021

First Posted (Actual)

January 25, 2021

Study Record Updates

Last Update Posted (Actual)

February 14, 2024

Last Update Submitted That Met QC Criteria

February 12, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PA12-1006 (Other Identifier: M D Anderson Cancer Center)
  • NCI-2020-07408 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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