Clinical trial NCT04723095: Establishing a Tumor Registry for Patients With Neuroendocrine Carcinoma of the Cervix
Official title: Establishing a Tumor Registry for Patients With Neuroendocrine Carcinoma of the Cervix
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: 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
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2021-01-25
Enrollment: 750
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with neuroendocrine cervical cancer

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.

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

Eligibility 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

Primary outcomes:
measure: Disease characterization data
timeFrame: through study completion, an average of 1 year
measure: Patient treatment data
timeFrame: through study completion, an average of 1 year
measure: Patient outcome data
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Robert T. Hillman
role: PRINCIPAL_INVESTIGATOR
References: