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

Stage IVA Cervical Cancer AJCC v8 Clinical Trial

— NeCTuR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04723095
• Other study ID #: PA12-1006
• Secondary ID: NCI-2020-07408PA
• Status: Recruiting
• Start date: May 16, 2013
• Est. completion date: January 1, 2044

Study information

• Verified date: February 2024
• Source: M.D. Anderson Cancer Center
• Contact: Michael M. Frumovitz
• Phone: 713-792-9599
• Email: nectur[@]mdanderson.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 750
• Est. completion date: January 1, 2044
• Est. primary completion date: January 1, 2044
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Neuroendocrine
• Carcinoma, Small Cell
• Cervical Large Cell Neuroendocrine Carcinoma
• Cervical Neuroendocrine Carcinoma
• Cervical Small Cell Carcinoma
• Cervical Undifferentiated Carcinoma
• Small Cell Lung 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
• Uterine Cervical Neoplasms

Intervention

Other:
• Follow-Up
Receive follow up
• Medical Chart Review
Review of medical records

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease characterization data	Information collected from retrospective and prospective review of medical records.	through study completion, an average of 1 year
Primary	Patient treatment data	Information collected from retrospective and prospective review of medical records.	through study completion, an average of 1 year
Primary	Patient outcome data	Information collected from retrospective and prospective review of medical records.	through study completion, an average of 1 year

External Links

•   University of Texas MD Anderson Cancer Center