eprintid: 10204755 rev_number: 7 eprint_status: archive userid: 699 dir: disk0/10/20/47/55 datestamp: 2025-02-14 10:57:49 lastmod: 2025-02-14 10:57:49 status_changed: 2025-02-14 10:57:49 type: article metadata_visibility: show sword_depositor: 699 creators_name: Bedia, Jacob S creators_name: Jacobs, Ian J creators_name: Ryan, Andy creators_name: Gentry-Maharaj, Aleksandra creators_name: Burnell, Matthew creators_name: Singh, Naveena creators_name: Manchanda, Ranjit creators_name: Kalsi, Jatinderpal K creators_name: Dawnay, Anne creators_name: Fallowfield, Lesley creators_name: Mcguire, Alistair J creators_name: Campbell, Stuart creators_name: Parmar, Mahesh KB creators_name: Menon, Usha creators_name: Skates, Steven J title: Estimating the ovarian cancer CA-125 preclinical detectable phase, in-vivo tumour doubling time, and window for detection in early stage: an exploratory analysis of UKCTOCS ispublished: pub divisions: UCL divisions: B02 divisions: D11 divisions: D65 divisions: J38 keywords: Science & Technology, Life Sciences & Biomedicine, Medicine, General & Internal, Medicine, Research & Experimental, General & Internal Medicine, Research & Experimental Medicine, CA-125 antigen, Blood, Carcinoma, Ovarian epithelial*, Early detection of cancer*, Longitudinal studies, Ovarian neoplasms*, Epidemiology, UKCTOCS, Mass screening, Biomarker, Preclinical history of cancer, Preclinical detectable phase, Natural history of cancer, Early diagnosis, UK COLLABORATIVE TRIAL, MUTATIONS, MORTALITY, SYMPTOMS, PROSTATE, ROUTES, WOMEN, RISK, LUNG note: Copyright © 2025 The Authors. Published by Elsevier B.V. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). abstract: Background: The ovarian cancer (OC) preclinical detectable phase (PCDP), defined as the interval during which cancer is detectable prior to clinical diagnosis, remains poorly characterised. We report exploratory analyses from the United Kingdom Collaborative Trial of Ovarian Cancer Screening (UKCTOCS). Methods: In UKCTOCS between Apr-2001 and Sep-2005, 101,314 postmenopausal women were randomised to no screening (NS) and 50,625 to annual multimodal screening (MMS) (until Dec-2011) using serum CA-125 interpreted by the Risk of Ovarian Cancer Algorithm (ROCA). All provided a baseline blood sample. Women with invasive epithelial OC diagnosed between randomisation and trial censorship (Dec-2014) in the MMS and NS arms with two or more CA-125 measurements, including one within two years of diagnosis were included. OC-free women (2:1 to cases) from the MMS arm provided information on baseline CA-125 distribution. CA-125 measurements were obtained from MMS results, secondary analysis of baseline samples, and medical records. PCDP duration and in-vivo tumour doubling time were estimated using the change-point model underlying ROCA. Early-stage (Stage I and II) PCDP was estimated from a Bayesian model for the probability of early stage given a CA-125 measurement. Findings: Of 541 women (2371 CA-125 measurements) with high-grade serous cancer (HGSC), 93% (504/541) secreted CA-125 into the circulation. Median CA-125 PCDP duration for clinically-diagnosed HGSC was 15.2 (IQR 13.1–16.9, 95% IPR 9.6–21.8) months, of which 11.9 (IQR 10.5–13.1, 95% IPR 7.5–16.5) months was in early stage. The median HGSC in-vivo tumour doubling time for cancers secreting CA-125 was 2.9 (IQR 2.3–3.7, 95% IPR 1.5–7.6) months. Interpretation: We report a comprehensive characterisation of the OC CA-125 PCDP. The 12-month window for early-stage detection and short tumour doubling time of HGSC provide a benchmark for researchers evaluating novel screening approaches including need to reduce diagnostic workup interval. Equally the findings provide urgent impetus for clinicians to reduce intervals from presentation to treatment onset. Funding: NCI Early Detection Research Network, Concord (MA) Detect Ovarian Cancer Early Fund, MRC Clinical Trials Unit at UCL Core Funding. date: 2025-02 date_type: published publisher: ELSEVIER official_url: https://doi.org/10.1016/j.ebiom.2024.105554 oa_status: green full_text_type: pub language: eng primo: open primo_central: open_green verified: verified_manual elements_id: 2353129 doi: 10.1016/j.ebiom.2024.105554 medium: Print-Electronic pii: S2352-3964(24)00590-5 lyricists_name: Gentry-Maharaj, Aleksandra lyricists_name: Menon, Usha lyricists_name: Parmar, Mahesh lyricists_id: AGENT07 lyricists_id: UMENO29 lyricists_id: MKBPA56 actors_name: Menon, Usha actors_name: Spencer, Susan actors_id: UMENO29 actors_id: SMSPE80 actors_role: owner actors_role: impersonator funding_acknowledgements: U01 CA152990 [National Cancer Institute (NCI) Early Detection Research Network]; U2C CA271871 [National Cancer Institute (NCI) Early Detection Research Network]; [Concord (MA) Detect Ovarian Cancer Early Fund]; U01 CA260758 [NCI]; MC_UU_00004/01 [MRC Clinical Trials Unit at UCL]; G9901012 [MRC]; G0801228 [MRC]; C1479/A2884 [Cancer Research UK]; [UK Department of Health]; [Eve Appeal]; 16/46/01 [NIHR (Health Technology Assessment grant)] full_text_status: public publication: eBioMedicine volume: 112 article_number: 105554 pages: 13 event_location: Netherlands issn: 2352-3964 citation: Bedia, Jacob S; Jacobs, Ian J; Ryan, Andy; Gentry-Maharaj, Aleksandra; Burnell, Matthew; Singh, Naveena; Manchanda, Ranjit; ... Skates, Steven J; + view all <#> Bedia, Jacob S; Jacobs, Ian J; Ryan, Andy; Gentry-Maharaj, Aleksandra; Burnell, Matthew; Singh, Naveena; Manchanda, Ranjit; Kalsi, Jatinderpal K; Dawnay, Anne; Fallowfield, Lesley; Mcguire, Alistair J; Campbell, Stuart; Parmar, Mahesh KB; Menon, Usha; Skates, Steven J; - view fewer <#> (2025) Estimating the ovarian cancer CA-125 preclinical detectable phase, in-vivo tumour doubling time, and window for detection in early stage: an exploratory analysis of UKCTOCS. eBioMedicine , 112 , Article 105554. 10.1016/j.ebiom.2024.105554 <https://doi.org/10.1016/j.ebiom.2024.105554>. Green open access document_url: https://discovery.ucl.ac.uk/id/eprint/10204755/1/Estimating%20the%20ovarian%20cancer%20CA-125%20preclinical%20detectable%20phase%2C%20in-vivo%20tumour%20doubling%20time%2C%20and%20window%20for%20detection%20in.pdf