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

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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	N/A and Over
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04723095
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	M.D. Anderson Cancer Center
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Robert T. Hillman
Principal Investigator Affiliation	M.D. Anderson Cancer Center
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	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 Website:	View Trial Website

Additional Details

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. On a case by case basis for up to 10 years to check status of disease and any further treatment received.

Arms & Interventions

Arms

: Observational (medical chart review)

Patients' medical records are reviewed retrospectively and prospectively. Patients are followed up by email, telephone, or U.S. mail on a case by case basis for up to 10 years to check status of disease and any further treatment received.

Interventions

Other: - Follow-Up

Receive follow up

Other: - Medical Chart Review

Review of medical records

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

M D Anderson Cancer Center, Houston, Texas

Status

Recruiting

Address

M D Anderson Cancer Center

Houston, Texas, 77030

Site Contact

Robert T. Hillman, MD

[email protected]

281-658-8887