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Not yet recruitingNCT06409416Updated Jun 18, 2024

Tumor Cell Plasticity and Aggressiveness in Human Non-small Cell Lung Cancer

An observational study in Lung Neoplasms and Progression, sponsored by Casa Sollievo della Sofferenza IRCCS. Not yet recruiting. Per ClinicalTrials.gov, last updated 2024-06-18.

Sponsored by Casa Sollievo della Sofferenza IRCCS · Observational

From the registry’s dates

  • Primary completion was expected by Jun 2025, 1 year 5 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
20
Sex
All
01

Study summary

Tumor cell plasticity (TCP) is a conubium of processes which lead to re-activation of developmental programs correlating with epithelial-to-mesenchymal transition, and ultimately leading to acquisition of stem cell properties and transdifferentiation potential. Little is known about the molecular mechanisms governing TCP in lung adenocarcinoma (LUAD), i.e. the most frequent lung cancer subtype. The investigators recently identified prognostic 7-miRNAs/10-mRNAs signatures which accurately identified aggressive LUAD among patients with early-stage disease (Stage I). Furthermore, the investigators showed that such tumors show TCP features i.e. mesenchymal and stem-cell traits, high-metastatic potential. Here, the investigators aim to explore by RNAseq and by immunophenotyping at a single-cell level (scRNAseq/AbSeq), the molecular features of aggressive LUAD to unveil the mechanisms triggering TCP. The investigators predict thier results will be relevant for the development of more effective therapeutic protocols for management of aggressive LUAD.

02

Conditions studied

  • Lung Neoplasms
  • Progression
03

In context

Lung Neoplasms

5,422 studies on the registry are indexed under Lung Neoplasms; 1,346 are open to participants now.

This study's planned enrollment of 20 is below the median of 200 across 1,434 observational studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Casa Sollievo della Sofferenza IRCCS is the lead sponsor of 19 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

patients undergoing surgery for confirmed diagnosis of lung adenocarcinoma

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • patients diagnosed with lung adenocarcinoma
  • treatment naive
  • undergoing primary surgery

Exclusion criteria

Exclusion Criteria:

  • patients with a previous history of cancer
  • previously treated by chemio/immuno/radio-therapy
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
20 participants (estimated)
Patient registry
No

Interventions

  • OtherAnalysis of diagnostic biomarkers

    The investigators will analyze TCP-biomarkers diagnostic by IHC, qRT-PCR and next-generation sequencing, in tumor and plasma samples of lung cancer patients.

06

What researchers measure

Primary outcomes

  1. TCP-biomarkers screening in a prospective cohort of lung cancer patients

    The investigators will: i) deconvolute the tumor epithelial cell heterogeneity of lung adenocarcinoma (LUAD) by coupling immunophenotype screening and single-cell RNAseq profiling of human LUAD samples; ii) identify subsets of LUAD cells with "active" tumor cell plasticity (TCP) using both our miRNA/RNA prognostic signatures, the C1-LUAD geneset (N=330), and previously identified signatures of lung cells high-cell plasticity (HCP) state; iii) explore the molecular features of TCP cell subsets by gene-network rewiring, pathway reconstruction analysis, and functional validation experiments of molecular "HUBs" controlling TCP pathways. Biomarkers of TCP will be also prioritized among TCP-hallmark genes and validated by immunohistochemistry (IHC/FACS) in human LUAD.

    Time frame: 36 months

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Study locations

No study locations are listed for this record.

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jul 2024; primary completion for Jun 2025, 11 months later.

Of 591 non-industry observational studies under Lung Neoplasms, half reached primary completion within 65 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 162. This study's planned 11 months is below that.

Counting every sponsor, half of 681 studies reached it within 57 months; a quarter within 25 and three quarters within 135.

How these figures are worked out, and which studies are left out of them.

Registered
May 7, 2024
First posted
May 10, 2024
StartEst.
Jul 1, 2024
Primary completionEst.
Jun 1, 2025
CompletionEst.
Jun 1, 2026
Last update
Jun 18, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 18, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06409416
Lead sponsor
Casa Sollievo della Sofferenza IRCCS
Collaborators
IRCCS Ospedale San Raffaele
Responsible party
Fabrizio Bianchi (Head, cancer Biomarkers Unit, Casa Sollievo della Sofferenza IRCCS) — Principal investigator
First posted
May 10, 2024
Start date
Jul 1, 2024 (estimated)
Primary completion
Jun 1, 2025 (estimated)
Completion
Jun 1, 2026 (estimated)
Last update
Jun 18, 2024

Study contacts

Fabrizio Bianchi, PhD
Contact
f.bianchi@operapadrepio.it
+390882416571

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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