Evidence map›Paper›PMID 34740331›Full record

ArticleBMC cancer2021

Molecular profiling of advanced soft-tissue sarcomas: the MULTISARC randomized trial.

Antoine Italiano, Derek Dinart, Isabelle Soubeyran, Carine Bellera, Hélène Espérou, Christelle Delmas, Noémie Mercier, Sabrina Albert, Ludivine Poignie, Anne Boland and 18 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMC cancer, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03784014 (Molecular Profiling of Advanced Soft-tissue Sarcomas. A Phase III Study), which is not on this map. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 1 pooled it
2.3field-weighted citation impact, top 10% of its field
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.

NCT03784014 phase3completednot on this map

Molecular Profiling of Advanced Soft-tissue Sarcomas. A Phase III Study

TypeinterventionalSponsorInstitut National de la Santé Et de la Recherche Médicale, FranceRan2019 to 2026Enrolled603ConditionsSoft Tissue SarcomaArmsNilotinib, Ceritinib, Capmatinib, Lapatinib, Trametinib
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 1 synthesis or guideline pooled it, 21 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Article
  4. Article
  5. Impact of anthracycline-based chemotherapy on RB1 gene methylation in peripheral blood leukocytes and biomarkers of oxidative stress and inflammation in sarcoma patients.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2024
    Article
  6. Article
  7. Article
  8. Review
  9. Review
  10. The Landscape of Immunotherapy for Retroperitoneal Sarcoma.Current oncology (Toronto, Ont.) · 2023
    Review
  11. Review
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

28 authors at 7 institutions in 1 country.

Antoine ItalianoDepartment of Medical Oncology, Institut Bergonié, University of Bordeaux, INSERM, Unité ACTION U1218, Bordeaux, France.
Derek DinartUniversity of Bordeaux, Inserm, Bordeaux Population Health Research Center, UMR 1219, CIC-EC 1401/EUCLID Clinical Trials Platform, Bordeaux, France. d.dinart@bordeaux.unicancer.fr.ORCID http://orcid.org/0000-0003-1815-3016
Isabelle SoubeyranDepartment of Biopathology, Institut Bergonié, U1218, Bordeaux, France.
Carine BelleraUniversity of Bordeaux, Inserm, Bordeaux Population Health Research Center, UMR 1219, CIC-EC 1401/EUCLID Clinical Trials Platform, Bordeaux, France.
Hélène EspérouInserm, Pôle de Recherche Clinique, 75013, Paris, France.
Christelle DelmasInserm, Pôle de Recherche Clinique, 75013, Paris, France.
Noémie MercierANRS (France Recherche Nord&sud Sida-hiv Hépatites), Clinical Trial Safety and Public Health, Paris, France.
Sabrina AlbertUniversity of Bordeaux, Inserm, Bordeaux Population Health Research Center, UMR 1219, CIC-EC 1401/EUCLID Clinical Trials Platform, Bordeaux, France.
Ludivine PoignieClinical Research and Clinical Epidemiology Unit, Institut Bergonié, Bordeaux, France.
Anne BolandUniversité Paris-Saclay, CEA, Centre National de Recherche en Génomique Humaine, 91057, Evry, France.
Aurélien BourdonU1218, Institut Bergonié, Institut national de la santé et de la recherche médicale, Bordeaux, France.
Damien GenesteU1218, Institut Bergonié, Institut national de la santé et de la recherche médicale, Bordeaux, France.
Quentin CavailleU1218, Institut Bergonié, Institut national de la santé et de la recherche médicale, Bordeaux, France.
Yec'han LaizetU1218, Institut Bergonié, Institut national de la santé et de la recherche médicale, Bordeaux, France.
Emmanuel KhalifaDepartment of Biopathology, Institut Bergonié, U1218, Bordeaux, France.
Céline AuzanneauDepartment of Biopathology, Institut Bergonié, U1218, Bordeaux, France.
Barbara SquibanDepartment of Biopathology, Institut Bergonié, U1218, Bordeaux, France.
Nathalène TruffauxDepartment of Biopathology, Institut Bergonié, U1218, Bordeaux, France.
Robert OlasoUniversité Paris-Saclay, CEA, Centre National de Recherche en Génomique Humaine, 91057, Evry, France.
Zuzana GerberUniversité Paris-Saclay, CEA, Centre National de Recherche en Génomique Humaine, 91057, Evry, France.
Cédrick WalletUniversity of Bordeaux, Inserm, Bordeaux Population Health Research Center, UMR 1219, CIC-EC 1401/EUCLID Clinical Trials Platform, Bordeaux, France.
Antoine BénardUniversity of Bordeaux, Inserm, Bordeaux Population Health Research Center, UMR 1219, CIC-EC 1401/EUCLID Clinical Trials Platform, Bordeaux, France.
Jean-Yves BlayDepartment of Medical Oncology, Centre Léon Bérard, Lyon, France.
Pierre Laurent-PuigSorbonne Paris Cité, Paris Descartes University, Georges Pompidou European Hospital, Paris, France.
Jean-François DeleuzeUniversité Paris-Saclay, CEA, Centre National de Recherche en Génomique Humaine, 91057, Evry, France.
Carlo LucchesiU1218, Institut Bergonié, Institut national de la santé et de la recherche médicale, Bordeaux, France.
Simone Mathoulin-PelissierUniversity of Bordeaux, Inserm, Bordeaux Population Health Research Center, UMR 1219, CIC-EC 1401/EUCLID Clinical Trials Platform, Bordeaux, France.
MULTISARC study group
Institut Bergonié · FRUniversité de Bordeaux · FRCommissariat à l'Énergie Atomique et aux Énergies Alternatives · FRInserm · FRAgence Nationale de Recherches sur le Sida et les Hépatites Virales · FRCentre Léon Bérard · FRUniversité Paris Cité · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSoft-tissue sarcomas (STS) represent a heterogeneous group of rare tumors including more than 70 different histological subtypes. High throughput molecular analysis (next generation sequencing exome [NGS]) is a unique opportunity to identify driver mutations that can change the usual one-size-fits-all treatment paradigm to a patient-driven therapeutic strategy. The primary objective of the MULTISARC trial is to assess whether NGS can be conducted for a large proportion of metastatic STS participants within a reasonable time, and, secondarily to determine whether a NGS-guided therapeutic strategy improves participant's outcome.

methodsThis is a randomized, multicentre, phase II/III trial inspired by the design of umbrella and biomarker-driven trials. The setting plans up to 17 investigational centres across France and the recruitment of 960 participants. Participants aged at least 18 years, with unresectable locally advanced and/or metastatic STS confirmed by the French sarcoma pathological reference network, are randomized according to 1:1 allocation ratio between the experimental arm "NGS" and the standard "No NGS". NGS will be considered feasible if (i) NGS results are available and interpretable, and (ii) a report of exome sequencing including a clinical recommendation from a multidisciplinary tumor board is provided to investigators within 7 weeks from reception of the samples on the biopathological platform. A feasibility rate of more than 70% is expected (null hypothesis: 70% versus alternative hypothesis: 80%). In terms of care, participants randomized in "No NGS" arm and who fail treatment will be able to switch to the NGS arm at the request of the investigator. DISCUSSION: The MULTISARC trial is a prospective study designed to provide high-level evidence to support the implementation of NGS in routine clinical practice for advanced STS participants, on a large scale.

trial registrationclinicaltrial.gov NCT03784014 .

Indexed as

High-Throughput Nucleotide SequencingSarcomaSoft Tissue NeoplasmsAdultClinical Trials, Phase II as TopicClinical Trials, Phase III as TopicCost-Benefit AnalysisExome SequencingFeasibility StudiesFranceHumansMulticenter Studies as TopicProspective StudiesRandomized Controlled Trials as TopicSample SizeTime FactorsBiomarker-drivenNext generation sequencingSoft-tissue sarcomasUmbrella

Identifiers

PMID34740331
PMCPMC8570026
OpenAlexW3210687617

What OpenQuestion holds

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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.