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

NCT ID: NCT04723095

Last Updated: 2025-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

750 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-05-16

Study Completion Date

2044-01-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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. All prospective patients will be contacted via email, telephone, or U.S. Mail on case by case basis for up to 10 years to check status of disease and any further treatment received. Project staff can also access the patient's M. D. Anderson Epic medical record for updates. Request for additional clinic and treatment notes will be submitted to external medical institutions listed in the physician information form in order to access updated notes for non- M. D. Anderson patients

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Observational (medical chart review)

Patients' medical records are reviewed retrospectively and prospectively. All prospective patients will be contacted via email, telephone, or U.S. Mail on case by case basis for up to 10 years to check status of disease and any further treatment received. Project staff can also access the patient's M. D. Anderson Epic medical record for updates. Request for additional clinic and treatment notes will be submitted to external medical institutions listed in the physician information form in order to access updated notes for non- M. D. Anderson patients.

Follow-Up

Intervention Type OTHER

Receive follow up

Medical Chart Review

Intervention Type OTHER

Review of medical records

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Follow-Up

Receive follow up

Intervention Type OTHER

Medical Chart Review

Review of medical records

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Active Follow-up Clinical Signs Follow-up CLSFUP Follow Up Followed Followup Chart Review

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

M.D. Anderson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Larissa A. Meyer

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

M D Anderson Cancer Center

Houston, Texas, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Larissa A. Meyer, MD

Role: CONTACT

713-745-0973

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Larissa A. Meyer, MD

Role: primary

713-745-0973

Related Links

Access external resources that provide additional context or updates about the study.

http://www.mdanderson.org

University of Texas MD Anderson Cancer Center

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NCI-2020-07408

Identifier Type: REGISTRY

Identifier Source: secondary_id

PA12-1006

Identifier Type: OTHER

Identifier Source: secondary_id

PA12-1006

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.