Evidence map›Paper›PMID 39766151›Full record

ArticleCancers2024

The Safety and Suitability of DNA Sequencing of Tissue Biopsies Performed on Patients Referred to a Phase I Unit.

Angela Esposito, Edoardo Crimini, Carmen Criscitiello, Carmen Belli, Roberta Scafetta, Raimondo Scalia, Grazia Castellano, Elisa Giordano, Jalissa Katrini, Liliana Ascione and 11 more

Abstract read
In one paragraph

Article in Cancers, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Immunohistochemistry for PTEN testing in HR +/HER2- metastatic breast cancer.Virchows Archiv : an international journal of pathology · 2025
    Review
  2. Article
  3. Article
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

21 authors.

Angela EspositoDivision of Early Drug Development, European Institute of Oncology, IRCCS, 20141 Milan, Italy.
Edoardo CriminiDivision of Early Drug Development, European Institute of Oncology, IRCCS, 20141 Milan, Italy.
Carmen CriscitielloDivision of Early Drug Development, European Institute of Oncology, IRCCS, 20141 Milan, Italy.ORCID 0000-0001-9064-0113
Carmen BelliDivision of Early Drug Development, European Institute of Oncology, IRCCS, 20141 Milan, Italy.ORCID 0000-0001-7067-7496
Roberta ScafettaDivision of Early Drug Development, European Institute of Oncology, IRCCS, 20141 Milan, Italy.
Raimondo ScaliaDivision of Early Drug Development, European Institute of Oncology, IRCCS, 20141 Milan, Italy.
Grazia CastellanoDivision of Early Drug Development, European Institute of Oncology, IRCCS, 20141 Milan, Italy.ORCID 0000-0003-2147-1672
Elisa GiordanoDivision of Early Drug Development, European Institute of Oncology, IRCCS, 20141 Milan, Italy.
Jalissa KatriniDivision of Early Drug Development, European Institute of Oncology, IRCCS, 20141 Milan, Italy.
Liliana AscioneDivision of Early Drug Development, European Institute of Oncology, IRCCS, 20141 Milan, Italy.ORCID 0000-0002-2807-7400
Luca Boscolo BieloDivision of Early Drug Development, European Institute of Oncology, IRCCS, 20141 Milan, Italy.ORCID 0000-0003-1026-3923
Matteo RepettoDivision of Early Drug Development, European Institute of Oncology, IRCCS, 20141 Milan, Italy.
Antonio MarraDivision of Early Drug Development, European Institute of Oncology, IRCCS, 20141 Milan, Italy.ORCID 0000-0002-7310-7824
Dario TrapaniDivision of Early Drug Development, European Institute of Oncology, IRCCS, 20141 Milan, Italy.
Gianluca Maria VaranoDivision of Interventional Radiology, European Institute of Oncology, IRCCS, 20141 Milan, Italy.
Daniele MaiettiniDivision of Interventional Radiology, European Institute of Oncology, IRCCS, 20141 Milan, Italy.
Paolo Della VignaDivision of Interventional Radiology, European Institute of Oncology, IRCCS, 20141 Milan, Italy.ORCID 0000-0002-8523-9226
Franco OrsiDivision of Interventional Radiology, European Institute of Oncology, IRCCS, 20141 Milan, Italy.ORCID 0000-0002-7330-0499
Elena Guerini RoccoDepartment of Oncology and Hemato-Oncology, University of Milan, 20122 Milan, Italy.
Nicola FuscoDepartment of Oncology and Hemato-Oncology, University of Milan, 20122 Milan, Italy.ORCID 0000-0002-9101-9131
Giuseppe CuriglianoDivision of Early Drug Development, European Institute of Oncology, IRCCS, 20141 Milan, Italy.ORCID 0000-0003-1781-2518

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundEarly-phase clinical trials offer a unique opportunity for patients with cancer. These trials often mandate biopsies to collect tumor tissue for research purposes, requiring patients to undergo invasive procedures. Some trials mandate molecular prescreening, but the success of these analyses relies on the quality and quantity of the tested materials. Additionally, bioptic procedures may result in complications.

methodsWe retrospectively examined the records of patients referred to the Early Drug Development (EDD) Unit of the European Institute of Oncology who underwent biopsies for research purposes between January 2014 and December 2022. Our objective was to assess the safety of biopsy procedures and adequacy of the samples for NGS testing.

resultsIn total, 355 out of 731 patients (48.6%) underwent protocol-mandated biopsies. The most frequent sites of biopsy were the liver, lymph nodes, skin, and breast. Histological diagnosis was achieved in 349 (98%) patients, and NGS testing was successfully conducted in 111/127 (88.4%) cases. Of the 16 unsuccessful NGS attempts, 9 were performed on liver tissue. Unsuccessful NGS testing was attributed to poor sample quality and/or quantity, and the success rate varied significantly based on the specific tests attempted. Complications occurred in a small proportion of patients (4.8%), and none were serious.

conclusionsThe non-negligible failure rate of NGS testing highlights the crucial need for implementing specific guidelines and Standard Operating Procedures for samples intended for NGS. With the use of a risk-based biopsy framework to guide clinical decisions, procedure-related complications may be minimized.

Indexed as

agnostic therapybiomarkerbiopsycancerdrug developmentnext-generation sequencingphase I trialsprecision oncologyreal worldtargeted therapies

Identifiers

PMID39766151
PMCPMC11674575

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Registered trials

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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.