Epithelial Ovarian CancerINFLUENCENCT03268876
The INFLUENCE of Cytoreduction on PRO in EOC
An observational study of Epithelial Ovarian Cancer, run by Haukeland University Hospital at 3 sites in Norway.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 years, women only
- Conditions the study is for
- Epithelial Ovarian Cancer
- How many people
- 70 participants
- Where
- 3 sitesNorway
- Study dates
- 3 Mar 2021to 31 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- Women only
- Adult, Older adult
Study population: Patients primary treated with primary surgery for advanced epithelial ovarian cancer at the participating institutions will be asked to participate.
Who may be able to join
- Epithelial ovarian cancer
- Stage > II
- ECOG < II
- Treated with primary surgery followed by chemotherapy
- Willing to participate and to sign the informed consent
Who cannot join
- < 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
Trial locations and contacts
3 sites in 1 country.
Norway3 sites
Haukeland University Hospital
Bergen, 5021
Sørlandet sykehus HF
Kristiansand
Stavanger University Hospital
Stavanger
About this study
Official title: The INFLUENCE of Cytoreduction on Patient Reported Outcomes in Patients With Epithelial Ovarian Cancer
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.
Read the detailed description
The patients will be recruited at their follow-up appointment after their surgery. At this consultation the patient will be informed about the final diagnosis and extent of disease and a plan for their further chemotherapeutic treatment will be developed. All patients will be offered carboplatin AUC 5 and paclitaxel 175mg/m2 q3w for 6 cycles [+ bevacizumab 7.5mg/kg q3w for 18 cycles in high-risk women of recurrence (IIIc not maximal debulked with a rest tumor of >1 cm2 and stage IV)]. In they fulfill the inclusion criteria and agree the inform consent formula will be signed. During the screening period the study team will secure that the necessary information needed is available and study specific test and analysis will be undertaken. After inclusion the study specific consultations will be scheduled coinciding with the patient regular appointments for treatment and follow-up. The patients will be followed at predetermined time points (after finalizing the chemotherapy; and every 3 months thereafter for 2 years).
- Conditions
- Epithelial Ovarian Cancer
- Keywords
- Epithelial ovarian cancer, Surgery, Quality of life
- Medical subject headings
- Carcinoma, Ovarian Epithelial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Global Health Score
Is there a relationship between QOL score and immunologic profiling in biological samples?
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2017
- Study start3 Mar 2021
- Primary completion28 Dec 2025 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epithelial Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Haukeland University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Helse Stavanger HF, Sorlandet Hospital HF
- Responsible party
- Sponsor
- Investigators
- Line Bjørge, MD, PhD, MBA, Principal investigator, Helse-Bergen HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03268876
- Sponsor's protocol ID
- 2017/941
- Acronym
- INFLUENCE
- Status last verified
- Oct 2024
- First submitted
- 29 Aug 2017
- Last updated
- 9 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The INFLUENCE of Cytoreduction on Patient Reported Outcomes in Patients With Epithelial Ovarian Cancer
- ClinicalTrials.gov ID
- NCT03268876
- Acronym / sponsor ID
- INFLUENCE / 2017/941
- Conditions
- Epithelial Ovarian Cancer
- Keywords
- Epithelial ovarian cancer, Surgery, Quality of life
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Collaborators
- Helse Stavanger HF, Sorlandet Hospital HF
- Study start
- 3 Mar 2021 (actual)
- Primary completion
- 28 Dec 2025 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 31 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The patients will be recruited at their follow-up appointment after their surgery. At this consultation the patient will be informed about the final diagnosis and extent of disease and a plan for their further chemotherapeutic treatment will be developed. All patients will be offered carboplatin AUC 5 and paclitaxel 175mg/m2 q3w for 6 cycles [+ bevacizumab 7.5mg/kg q3w for 18 cycles in high-risk women of recurrence (IIIc not maximal debulked with a rest tumor of >1 cm2 and stage IV)]. In they fulfill the inclusion criteria and agree the inform consent formula will be signed. During the screening period the study team will secure that the necessary information needed is available and study specific test and analysis will be undertaken. After inclusion the study specific consultations will be scheduled coinciding with the patient regular appointments for treatment and follow-up. The patients will be followed at predetermined time points (after finalizing the chemotherapy; and every 3 months thereafter for 2 years).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Patients primary treated with primary surgery for advanced epithelial ovarian cancer at the participating institutions will be asked to participate.
Key inclusion criteria (5 listed)
- Epithelial ovarian cancer
- Stage > II
- ECOG < II
- Treated with primary surgery followed by chemotherapy
- Willing to participate and to sign the informed consent
Key exclusion criteria (8 listed)
- < 18 years old
- Borderline and non-epithelial ovarian tumors
- Stage < II
- Advanced ovarian cancer submitted to neoadjuvant chemotherapy
- ECOG 3-4
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mean Global Health Score
Time frame: 2 years
Is there a relationship between QOL score and immunologic profiling in biological samples?
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Line Bjørge, MD, PhD, MBA principal investigator
Helse-Bergen HF
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epithelial Ovarian Cancer, run by Haukeland University Hospital at 3 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Global Health Score (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2024.