Publications by authors named "Robert Woolas"

The 28-days-to-diagnosis pathway is the current expected standard of care for women with symptoms of ovarian cancer in the UK. However, the anticipated conversion rate of symptoms to cancer is only 3%, and use of the pathway is increasing. A rapid triage at the moment of receipt of the referral might allow resources to be allocated more appropriately.

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  • The UKCTOCS study aimed to explore the symptoms of preclinical invasive epithelial ovarian cancer (iEOC) in women, particularly by comparing symptoms between those diagnosed through screening (PC) and those diagnosed clinically (CD).
  • Out of 1133 women diagnosed with iEOC, those in the PC group were younger at diagnosis and reported fewer symptoms overall compared to the CD group, although abdominal symptoms were common in both groups.
  • The research suggests that early signs of tubo-ovarian cancer might be more complex than previously thought, highlighting the need to reassess what symptoms should trigger medical evaluation for better early detection.
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Background: In UKCTOCS, there was a decrease in the diagnosis of advanced stage tubo-ovarian cancer but no reduction in deaths in the multimodal screening group compared with the no screening group. Therefore, we did exploratory analyses of patients with high-grade serous ovarian cancer to understand the reason for the discrepancy.

Methods: UKCTOCS was a 13-centre randomised controlled trial of screening postmenopausal women from the general population, aged 50-74 years, with intact ovaries.

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  • Ovarian cancer remains a serious health issue, particularly for postmenopausal women; the UKCTOCS trial was initiated to evaluate if screening could lower mortality rates associated with the disease.
  • The study involved over 202,000 postmenopausal women who were randomly assigned to one of three groups: multimodal screening, transvaginal ultrasound screening, or no screening, and data was collected over a median follow-up period of 16.3 years.
  • Results showed that the detection rates of ovarian and tubal cancer were similar across all groups, indicating that neither type of screening significantly impacted the mortality from these cancers.
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  • Randomized trials for ovarian cancer screening haven't shown a reduction in mortality, but they provide useful data on screening effectiveness.
  • In the UKCTOCS trial, 44,799 women were screened annually with transvaginal ultrasound over nearly a decade, leading to 280,534 screenings and 960 surgeries from positive results.
  • Out of detected cancers, 37.5% of invasive epithelial cases were at Stage I/II, but the overall sensitivity of the ultrasound was low (68.5%) suggesting it may not be effective as a first line screening method in the general population.
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  • The study revisits the analysis methods for long-term mortality outcomes in a cancer screening trial, due to advancements in statistical methods and new evidence regarding delayed effects.
  • In consultation with experts, three analysis options were considered, with most advocating for a new method that accounts for delayed mortality effects.
  • The final decision was to use the Versatile test for better accuracy, highlighting the need for improved consensus on mortality outcome reporting in cancer trials.
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Background: There is a trend to increasing use of routinely collected health data to ascertain outcome measures in trials. We report on the completeness and accuracy of national ovarian cancer and death registration in the United Kingdom Collaborative Trial of Ovarian Cancer Screening (UKCTOCS).

Methods: Of the 202,638 participants, 202,632 were successfully linked and followed through national cancer and death registries of Northern Ireland, Wales and England.

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Objective: There are widespread efforts to increase symptom awareness of 'pelvic/abdominal pain, increased abdominal size/bloating, difficulty eating/feeling full and urinary frequency/urgency' in an attempt to diagnose ovarian cancer earlier. Long-term survival of women with these symptoms adjusted for known prognostic factors is yet to be determined. This study explored the association of symptoms, routes and interval to diagnosis and long-term survival in a population-based cohort of postmenopausal women diagnosed with invasive epithelial tubo-ovarian cancer (iEOC) in the 'no screen' (control) UKCTOCS arm.

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Background: To assess the within-trial cost-effectiveness of an NHS ovarian cancer screening (OCS) programme using data from UKCTOCS and extrapolate results based on average life expectancy.

Methods: Within-trial economic evaluation of no screening (C) vs either (1) an annual OCS programme using transvaginal ultrasound (USS) or (2) an annual ovarian cancer multimodal screening programme with serum CA125 interpreted using a risk algorithm (ROCA) and transvaginal ultrasound as a second-line test (MMS), plus comparison of lifetime extrapolation of the no screening arm and the MMS programme using both a predictive and a Markov model.

Results: Using a CA125-ROCA cost of £20, the within-trial results show USS to be strictly dominated by MMS, with the MMS vs C comparison returning an incremental cost-effectiveness ratio (ICER) of £91 452 per life year gained (LYG).

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Objective: There has been considerable interest in the impact of reproductive factors on health but there are little data on how these have varied over time. We explore trends in reproductive/lifestyle factors of postmenopausal British women by analysing self-reported data from participants of the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS).

Design: Prospective birth cohort analysis.

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Background: Ovarian cancer has a poor prognosis, with just 40% of patients surviving 5 years. We designed this trial to establish the effect of early detection by screening on ovarian cancer mortality.

Methods: In this randomised controlled trial, we recruited postmenopausal women aged 50-74 years from 13 centres in National Health Service Trusts in England, Wales, and Northern Ireland.

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Article Synopsis
  • The study explored cancer screening strategies, specifically focusing on the use of a risk algorithm for interpreting changes in the biomarker CA-125 to improve ovarian cancer detection rates.
  • In a clinical trial involving over 46,000 women, the combination of annual CA-125 testing with the risk of ovarian cancer algorithm (ROCA) demonstrated superior sensitivity compared to traditional single-threshold biomarker methods.
  • Results indicated that the ROCA method identified a greater percentage of invasive epithelial ovarian cancers, highlighting the potential for improved screening outcomes through a more nuanced risk assessment approach.
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Background: Robotic surgery in gynaecological oncology is a rapidly developing field as it offers several technical advantages over conventional laparoscopy. An audit was performed on the outcome of robotic surgery during our learning curve and compared with recent well-established laparoscopic procedure data.

Method: Following acquisition of the da Vinci Surgical System (Intuitive Surgical, Inc.

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  • The UKCTOCS trial aimed to decrease the 'healthy volunteer effect' by randomly inviting women, rather than allowing self-referrals, but found that participants were still healthier than the general population.
  • Between 2001 and 2005, over 202,000 postmenopausal women took part, with follow-up periods showing a significant gap in mortality compared to national averages, especially for younger women and those with extreme BMI.
  • Results indicated a clear link between socioeconomic status and higher mortality rates, with invited participants being less deprived than the general population, suggesting that the method of recruitment does not fully eliminate the healthy volunteer effect.
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Background: The increase in the worldwide incidence of endometrial cancer relates to rising obesity, falling fertility, and the ageing of the population. Transvaginal ultrasound (TVS) is a possible screening test, but there have been no large-scale studies. We report the performance of TVS screening in a large cohort.

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Objective: To evaluate cytological surveillance for women older than 50 years, to detect recurrent or residual disease after treatment of cervical intraepithelial neoplasia by loop excision.

Materials And Methods: Women undergoing a large loop excision for high-grade squamous intraepithelial lesion or glandular cytological abnormalities during a period of 4 years (2000-2003) were identified from the colposcopy database. Women younger than 50 years or with a history of previous loop excision were excluded.

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Introduction: Vulval cancer is a disease of an increasing elderly population and consequently comorbidities are common. These conditions may preclude the application of standard therapy.

Objective: To review the outcome of women with vulval cancer older than 80 years comparing those who received recommended treatment (protocol-adherent) with those who did not (protocol-violated).

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Background: Ovarian cancer has a high case-fatality ratio, with most women not diagnosed until the disease is in its advanced stages. The United Kingdom Collaborative Trial of Ovarian Cancer Screening (UKCTOCS) is a randomised controlled trial designed to assess the effect of screening on mortality. This report summarises the outcome of the prevalence (initial) screen in UKCTOCS.

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Article Synopsis
  • - The study successfully recruited over 200,000 postmenopausal women for the UK Collaborative Trial of Ovarian Cancer Screening by addressing various logistic challenges and building strong support at trial centers.
  • - Out of approximately 1.24 million women invited, 23.2% expressed eligibility and interest, with a notable 73.6% attending recruitment appointments, showing variable acceptance rates among different centers.
  • - The findings emphasize that thorough planning and active management are crucial for recruitment success, highlighting the need for dedicated oversight and tailored strategies for individual trial locations.
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Objective: Currently available tumor markers for ovarian cancer are still inadequate in both sensitivity and specificity to be used for population-based screening. Artificial neural network (ANN) as a modeling tool has demonstrated its ability to assimilate information from multiple sources and to detect subtle and complex patterns. In this paper, an ANN model was evaluated for its performance in detecting early stage epithelial ovarian cancer using multiple serum markers.

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  • Intrauterine progesterone therapy, specifically using the levonorgestrel intrauterine system (Mirena), may be a simpler treatment option for women with Stage I Grade I endometrial cancer who are not suitable for surgery.
  • A study involving four women showed that while one achieved complete regression of the cancer after six months, others did not respond, leading to a surgical intervention where endometrial cancer was still present.
  • The findings suggest that relying on intrauterine progesterone therapy as a definitive treatment for early endometrial cancer might be questionable.
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  • This study explores improving early-stage ovarian cancer detection by combining multiple biomarkers (CA-125II, CA 15-3, CA 72-4, and M-CSF), leading to increased preoperative sensitivity while keeping a low referral rate for ultrasounds.
  • Results showed that the combination of these biomarkers can raise sensitivity for early-stage disease from 45% (CA-125II alone) to 70% (using all markers), while maintaining a very high specificity rate of 98%.
  • The study suggests that using mixture discriminant analysis (MDA) is an effective method for merging biomarker data to enhance screening processes in ovarian cancer detection.
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Changes in the management of vulval cancer.

Best Pract Res Clin Obstet Gynaecol

August 2003

Vulval carcinoma is relatively rare. The disease spreads from the vulva through embolization to the locoregional lymphatic station, the inguinofemoral nodes. Prior to this event cure can be achieved, but rarely predicted with certainty.

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  • The study analyzed data from 100 women with Stage I endometrial cancer, focusing on the effects of omental biopsy in diagnosing extrapelvic disease.* -
  • Out of the participants, 80 underwent an omental biopsy, with six cases showing adenocarcinoma in the omentum; no significant complications were reported from the procedure.* -
  • The findings suggest that visual inspection and biopsy of the omentum during surgery can reveal more extensive disease, potentially changing treatment plans for around 10% of patients who may need additional pelvic radiation.*
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