Evidence map›Paper›PMID 40659403›Full record

Observational studyBMJ open2025

Participants' perspectives of the advanced ovarian cancer biomarker study VALTIVE1: a qualitative study.

Daniella Holland-Hart, Margherita Carucci, Magdalena Slusarczyk, Mirella Longo, Susan Campbell, Alys Irving, Simon Noble, Gordon Jayson, Noreen Hopewell-Kelly

Erratum issued Registry-linked trialAbstract readMulticenter StudyObservational Study
In one paragraph

Observational study in BMJ open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT04523116 (Validation of Tie2 as the First Tumour Vascular Response Biomarker for VEGF Inhibitors), 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.

NCT04523116 unknown statusnot on this map

Validation of Tie2 as the First Tumour Vascular Response Biomarker for VEGF Inhibitors: Optimising the Design of a Subsequent Randomised Discontinuation Trial: VALTIVE1

TypeobservationalSponsorUniversity of ManchesterRan2021 to 2023Enrolled176ConditionsOvary Cancer
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

5 · Who and what money

Authors and funding

9 authors.

Daniella Holland-HartCardiff University, Cardiff, UK Holland-HartD@Cardiff.ac.uk.ORCID http://orcid.org/0000-0002-1127-5152
Margherita CarucciCardiff University, Cardiff, UK.ORCID http://orcid.org/0009-0002-1687-8873
Magdalena SlusarczykCardiff University, Cardiff, UK.
Mirella LongoCardiff University, Cardiff, UK.ORCID http://orcid.org/0000-0002-9867-3806
Susan CampbellCardiff University, Cardiff, UK.
Alys IrvingCardiff University, Cardiff, UK.
Simon NobleCardiff University, Cardiff, UK.
Gordon JaysonThe Christie NHS Foundation Trust, Manchester, UK.
Noreen Hopewell-KellyCardiff University, Cardiff, UK.ORCID http://orcid.org/0000-0002-0699-0178

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesVALTIVE1 is a multi-centre, single-arm, non-interventional biomarker study for patients with advanced ovarian cancer. Plasma samples (Tie2 concentration) are collected to detect vascular control in tumours during standard treatment with chemotherapy and bevacizumab. This qualitative study embedded in VALTIVE1 aimed to assess the acceptability and feasibility of a potential VALTIVE2 trial. It explored the participants' perceptions of the study and treatments and how they might feel if bevacizumab were discontinued based on the results from the biomarker test.

designThis qualitative study used semi-structured telephone interviews, which were analysed using deductive and inductive thematic analysis. SETTINGS: Cancer treatment sites in the UK.

participantsParticipants recruited to VALTIVE1 were invited to take part in qualitative interviews. 11 female participants took part from four clinical sites.

resultsParticipants reported that they experienced side effects attributed to bevacizumab, including stiffness, pain, fatigue, nose bleeds and muscle aches. Participants felt that combining chemotherapy and bevacizumab may have increased the severity of the side effects they experienced. Most participants felt that it was acceptable, if not preferable, to be allocated to a group in a future VALTIVE2 study where bevacizumab may be discontinued according to the results from the biomarker test. A clear preference of participants was to be informed of the biomarker test results, health status and treatment side effects.

conclusionA future trial should consider ensuring all participants have access to test results, as participants indicated a preference to know whether bevacizumab was working and to discontinue bevacizumab if it had not prevented tumour growth based on the biomarker results. Comprehensive and ongoing information and support regarding treatment side effects should be provided to all participants throughout their cancer pathways and trials. TRIAL REGISTRATION NUMBER: NCT04523116.

Indexed as

Antineoplastic Agents, ImmunologicalBevacizumabBiomarkers, TumorOvarian NeoplasmsAdultAgedFeasibility StudiesFemaleHumansInterviews as TopicMiddle AgedQualitative ResearchUnited KingdomAntineoplastic Agents, ImmunologicalBevacizumabBiomarkers, TumorGynaecological oncologyONCOLOGYPatient-Centered CareQUALITATIVE RESEARCH

Identifiers

PMID40659403
PMCPMC12258328

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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.