NeCTuR: Tumor Registry for Patients With Neuroendocrine Cancer of the Cervix

Sponsor

M.D. Anderson Cancer Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT04723095

Collaborator

(none)

750

Enrollment

Location

367.5

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
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	Other: Follow-Up Other: Medical Chart Review

Detailed Description

PRIMARY OBJECTIVES:

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

Study Type:

Observational

Anticipated Enrollment :

750 participants

Observational Model:

Cohort

Time Perspective:

Other

Official Title:

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

Actual Study Start Date :

May 16, 2013

Anticipated Primary Completion Date :

Jan 1, 2044

Anticipated Study Completion Date :

Jan 1, 2044

Arms and Interventions

Arm	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: Follow-Up Receive follow up Other Names: Active Follow-up Clinical Signs Follow-up CLSFUP Follow Up Followed Followup Other: Medical Chart Review Review of medical records Other Names: Chart Review

Arm

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: Follow-Up

Receive follow up

Other Names:

Active Follow-up

Clinical Signs Follow-up

CLSFUP

Follow Up

Followed

Followup

Other: Medical Chart Review

Review of medical records

Other Names:

Chart Review

Outcome Measures

Primary Outcome Measures

Disease characterization data [through study completion, an average of 1 year]
Information collected from retrospective and prospective review of medical records.
Patient treatment data [through study completion, an average of 1 year]
Information collected from retrospective and prospective review of medical records.
Patient outcome data [through study completion, an average of 1 year]
Information collected from retrospective and prospective review of medical records.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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