Predicting Outcome in Cervix Carcinoma: a Prospective Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01825005

Acronym

POCER

Enrollment

423

Registered

2013-04-05

Start date

2013-02-28

Completion date

2018-08-31

Last updated

2019-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Cancer

Keywords

cervical cancer

Brief summary

The main aim is to validate and improve the predictive model for survival and toxicity in patients with cervical cancer through multicentric prospective data collection. The data contain information on patient, tumor and treatment characteristics. For this study, additional health related QOL scores will be assessed using the EORTC Quality of Life Questionair-CX24 and C30. The long term aim, beyond this specific study, is to build a Decision Support System based on the predictive model validated in this study.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* histological or cytological proven cervical cancer * informed consent according to national rules

Exclusion criteria

* no histological or cytological proven cervical cancer * no informed consent according to national rules

Design outcomes

Primary

Measure	Time frame	Description
five-year overall survival rate	5 years after treatment	assessment of the overall survival 5 years after treatment

Secondary

Measure	Time frame	Description
three-year local disease free survival	3 years	assessment of local disease free survival, 3 year after treatment
five-year distant disease free survival	5 years	assessment of distant disease free survival,5 years after treatment
three-year distant disease free survival	3 years	assessment of distant disease free survival, 3 years after treatment
number of participants with early adverse events as a measure of safety and tolerability	2 months	—
number of participants with late adverse events as a measure of safety and tolerability	5 years	—
five-year local disease free survival	5 years	assessment of local disease free survival, 5 years after treatment

Countries

Netherlands, South Africa

Outcome results