The INFLUENCE of Cytoreduction on PRO in EOC

NCT03268876 | Active Not Recruiting

• 1 other identifier: 2017/941
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 3

Brief Summary

Based on an improved understanding of how the extent of successful cytoreduction is influenced both by inherent tumor biological characteristics as well as the aggressiveness of the surgical approach this project aims to better define the value of cytoreduction and to use the knowledge gained to develop more individualized therapy and follow-up. This will be achieved through a translational biomedical research approach. Due to the research group's traditions clinical phenotyping, biomarker identification, and clinical trials will be the focus.

Conditions

Epithelial Ovarian Cancer

Keywords

Epithelial ovarian cancer; Surgery; Quality of life

Outcome Measures

Primary Outcomes (1)

• Mean Global Health Score

  Is there a relationship between QOL score and immunologic profiling in biological samples?

  2 years

Study Arms (1)

Epithelial ovarial cancer

Patients primary treated with primary surgery for advanced epithelial ovarian cancer (\> stage IIa) at the participating institutions will be asked to participate.

Eligibility Criteria

• Age: 18 Years - 100 Years
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients primary treated with primary surgery for advanced epithelial ovarian cancer at the participating institutions will be asked to participate.

You may qualify if:

• Epithelial ovarian cancer
• Stage \> II
• ECOG \< II
• Treated with primary surgery followed by chemotherapy
• Willing to participate and to sign the informed consent

You may not qualify if:

• \< 18 years old
• Borderline and non-epithelial ovarian tumors
• Stage \< II
• Advanced ovarian cancer submitted to neoadjuvant chemotherapy
• ECOG 3-4
• Pregnancy
• Severe cardiopulmonary disease
• Patients participating in QoL intervention studies

Sponsors & Collaborators

• Haukeland University Hospital: lead
• Helse Stavanger HF: collaborator
• Sorlandet Hospital HF: collaborator

Study Sites (3)

Haukeland University Hospital

Bergen, 5021, Norway

Location

Sørlandet sykehus HF

Kristiansand, Norway

Location

Stavanger University Hospital

Stavanger, Norway

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood, urine and tumor biopsies

MeSH Terms

Conditions

Carcinoma, Ovarian Epithelial

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Ovarian Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Line Bjørge, MD, PhD, MBA

  Helse-Bergen HF

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2017
• First Posted: August 31, 2017
• Study Start: March 3, 2021
• Primary Completion: December 28, 2025
• Study Completion (Estimated): December 31, 2030
• Last Updated: October 9, 2024

Record last verified: 2024-10

Locations

NO (3)