Predicting Outcome in Cervix Carcinoma: a Prospective Study

NCT ID: NCT01825005

Last Updated: 2019-05-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

423 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-02-28

Study Completion Date

2018-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cervical Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

group 1:surgery

treatment = surgery only

No interventions assigned to this group

group 2: radiotherapy

treatment = radiotherapy only

No interventions assigned to this group

group 3: RT and CT, and/or hyperthermia

treatment= radiotherapy combined with chemotherapy and/or hyperthermia

No interventions assigned to this group

group 4: stage IVb , any treatment

cervical cancer stage IV b, treatment = any systemic or radiation therapy and supportive care

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Maastricht Radiation Oncology

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

P Lambin, Prof

Role: PRINCIPAL_INVESTIGATOR

Maastricht University hospital, dep of radiotherapy (Maastro clinic)

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Maastricht University Hospital

Maastricht, , Netherlands

Site Status

Bloemfontein medicross

Bloemfontein, Free State, South Africa

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Netherlands South Africa

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

12-4-008

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Cervix:Hypoxia, Interstitial Fluid Pressure and GSH Levels
NCT00188539 ACTIVE_NOT_RECRUITING PHASE2
Predictive Assays In Cervix Cancer
NCT01181375 ACTIVE_NOT_RECRUITING NA