Evidence map›Paper›PMID 39907536›Full record

ArticleActa oncologica (Stockholm, Sweden)2025

Determining the effect of frailty on survival in advanced ovarian cancer: study protocol for a prospective multicentre national cohort study (FOLERO).

Daniel Hunde, Niklas Ekerstad, Mihaela Asp, Päivi Kannisto, Madelene Wedin, Charlotte Palmqvist, Pernilla Dahm-Kähler, Yvonne Brandberg, Mirna Abraham-Nordling, Kristina Åhlund and 3 more

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in Acta oncologica (Stockholm, Sweden), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06298877 (Frailty, Quality Of Life and Early Reversal of Temporary Defunctioning Stoma in Ovarian Cancer), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06298877 narecruitingnot on this map

Frailty, Quality Of Life and Early Reversal of Temporary Defunctioning Stoma in Ovarian Cancer (FOLERO) : A Prospective Cohort Study to Determine the Effect of Frailty on Survival and to Assess Early Reversal of Temporary Intestinal Stoma

TypeinterventionalSponsorSahar SalehiRan2024 to 2029Enrolled450ConditionsOvarian CancerArmsFrailty and Quality of Life evaluation
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors.

Daniel HundeDepartment of Women´s and Children´s Health, Division of Obstetrics and Gynecology, Karolinska Institutet, and Department of Pelvic Cancer, Karolinska University Hospital, Stockholm, Sweden.
Niklas EkerstadDepartment of Health, Medicine and Caring Sciences, Linköping University, Linköping, Sweden.
Mihaela AspDepartment of Clinical Science, Division of Obstetrics and Gynecology Lund University, and Department of Obstetrics and Gynecology, Skåne University Hospital, Lund, Sweden.
Päivi KannistoDepartment of Clinical Science, Division of Obstetrics and Gynecology Lund University, and Department of Obstetrics and Gynecology, Skåne University Hospital, Lund, Sweden.
Madelene WedinDepartment of Biomedical and Clinical Sciences Linköping University, and, Department of Obstetrics and Gynecology, Linköping University Hospital, Linköping, Sweden.
Charlotte PalmqvistDepartment of Obstetrics and Gynecology , Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, and Department of Gynecology and Obstetrics Sahlgrenska University Hospital, Gothenburg, Sweden.
Pernilla Dahm-KählerDepartment of Obstetrics and Gynecology , Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, and Department of Gynecology and Obstetrics Sahlgrenska University Hospital, Gothenburg, Sweden.
Yvonne BrandbergDepartment of Oncology and Pathology, Karolinska Institutet, Stockholm, Sweden.
Mirna Abraham-NordlingDepartment of Molecular Medicine and Surgery, Karolinska Institutet, and Department of Pelvic Cancer, Karolinska University Hospital, Stockholm, Sweden.
Kristina ÅhlundUniversity West, Trollhättan, Sweden and NU Hospital Group, Trollhättan-Uddevalla, Sweden.
Vilhelm MörlinDepartment of Women´s and Children´s Health, Division of Obstetrics and Gynecology, Karolinska Institutet, and Department of Pelvic Cancer, Karolinska University Hospital, Stockholm, Sweden.
Nina Groes-KofoedDepartment of Women´s and Children´s Health, Division of Obstetrics and Gynecology, Karolinska Institutet, and Department of Pelvic Cancer, Karolinska University Hospital, Stockholm, Sweden.
Sahar SalehiDepartment of Women´s and Children´s Health, Division of Obstetrics and Gynecology, Karolinska Institutet, and Department of Pelvic Cancer, Karolinska University Hospital, Stockholm, Sweden. sahar.salehi@regionstockholm.se.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

background and purposeThere is an urgent need to improve patient-selection to surgical treatment in advanced ovarian cancer as our results showed that cytoreductive surgery was without effect or even detrimental in a yet unknown subgroup of women. With an ageing population, 30% of women with advanced ovarian cancer in Sweden are >75 years. Nevertheless, there are no recommendations on patient-selection, albeit treating an unselected population in a public and centralized health care setting. Little attention has been placed on frailty assessments in oncology, despite their potential to stratify the risk of adverse outcome and mortality. Consequently, we hypothesize that frailty is a predictor of poor survival. PATIENTS AND

methodsIn this Swedish multi-centre prospective cohort study, where the exposure is frailty, consecutive women with advanced ovarian cancer scheduled for surgery with curative intent are eligible for inclusion. Three different frailty instruments are evaluated preoperatively, blinded to the caregiver. The primary outcome is 2-year overall survival. With a fixed sample size of 450 patients, a two-sided α of 0.05 and β of 0.20, the study is powered to detect a difference in 2-year survival of 12.5% by frailty, assuming a 20% prevalence of frailty. The result of the study will have a direct impact on clinical management and patient-selection as the results are expected to have a high external validity. Total study-time is 5 years, with 3 years of accrual. All participating centres started accrual by September 2024. Presentation of data on primary outcome is expected 2029. STUDY REGISTRATION: ClinicalTrials.gov NCT06298877.

Indexed as

FrailtyOvarian NeoplasmsAgedAged, 80 and overCytoreduction Surgical ProceduresFemaleHumansMiddle AgedMulticenter Studies as TopicPatient SelectionProspective StudiesSurvival RateSweden

Identifiers

PMID39907536
PMCPMC11816292

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.