SHALLOW ROUTE
Sponsor study identifier
observational
50
1 country
1
Study Start
January 5, 2025
Actual (reported)Primary Completion
January 4, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
January 4, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
High-grade serous ovarian carcinoma (HGSOC) is the deadliest gynaecological tumour. The 5-year overall survival rate for advanced-stage disease is less than 30 per cent, due to diagnosis at an advanced stage. There is currently no validated screening test for ovarian cancer. According to the literature, the current hypothesis is that HGSOCs develop primarily from the distal part of the fallopian tube, which is anatomically close to the lower genital tract. Tumour cells have even been observed in cervical smears. Studies suggest that early diagnosis of HGSOC is possible non-invasively by detecting pathogenic variants of the TP53 gene in DNA extracted from cervical smears. Studies suggest that early diagnosis of HGSOC is possible using non-invasive methods by detecting pathogenic variants in the TP53 gene in deoxyribonucleic acid (DNA) extracted from cervical smears. In 2023, whole-genome sequencing (WGS) of DNA extracted from cervical smears to detect genomic instability successfully identified the presence of high-grade serous ovarian cancer up to nine years before diagnosis. This study demonstrates the feasibility of early diagnosis of ovarian cancer using genomic instability analysis via Shallow-coverage whole-genome sequencing (sWGS) on DNA obtained from cervical smears. This study aim to confirm the feasibility of diagnosing high-grade serous ovarian carcinoma by analysing genomic instability via sWGS on DNA extracted from liquid-based cervical smears, using a homogeneous series of samples from patients treated at the Toulouse University Cancer Institute-Oncopole (IUCT-Oncopole).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 4, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 5, 2025
Actual (reported)September 8, 2026
Actual (reported)September 16, 2026
Actual (reported)January 4, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
January 4, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Proportion of patients with a positive CPA test on tumour and cervical samples measure
The primary endpoint is the proportion of patients with a positive CPA test on tumour and cervical samples. This is defined as the ratio of the number of patients with a positive test on tumour and cervical samples to the total number of evaluable patients (i.e. those with interpretable test results). The tissue analysis will serve as a negative control for each patient.
For each patient at baseline
Clinical ans pathological data description
At baseline
Women with high grade serous ovarian carcinoma treated at Toulouse university of cancer-Oncopole.
Institut Claudius Regaud
Toulouse, 31059, France
Ovarian tumors tissues, cervical smear
Giulio Ricotta, Dr
Institut Claudius Regaud
First Submitted
September 8, 2026
First Posted
September 16, 2026
Study Start
January 5, 2025
Actual (reported)Primary Completion
January 4, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Contact the study team to confirm eligibility.
Study Completion
January 4, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
September 16, 2026
Record last verified: 2026-09
There is not a plan to make IPD available
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Source: ClinicalTrials.gov.
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