Investigation at the primary care center followed by further investigation at Diagnostiskt Centrum, Kristianstad General Hospital

Investigation at the primary care center followed by further investigation at Helsingborg General Hospital

Patients who are suspected of having cancer after investigation at the primary care center will be referred to Diagnostiskt Centrum. Each patient who is referred to Diagnostiskt Centrum will undergo the following: (1) clinical chemistry/microbiology tests; (2) medical history; (3) objective clinical examination; and (4) taking of blood samples for analysis of biomarkers. If necessary, patients will also undergo the following: (5) additional laboratory tests; (6) biopsy; (7) X-ray of painful joints; (8) CT scan of the neck, thorax, abdomen, and/or pelvis; (9) mammography and gynecological examination; (10); gastroscopy and/or colonoscopy; and (11) further investigation (e.g., PET-CT scan).

Diagnostiskt Centrum

Jan Sundquist, MD, PhD

The aim of this study is to evaluate a new cancer diagnosis center (Diagnostiskt Centrum, DC) in Kristianstad, Sweden. Patients aged ≥ 18 years who are suspected of having serious illness but who have no organ-specific symptoms will be referred to the DC for further investigation after preliminary assessment in primary care. The overall purpose of the study is to evaluate whether the DC meets its target time for diagnosing cancer. In addition, we will evaluate secondary issues, such as survival, to determine whether this pilot project merits extension to other parts of southern Sweden.

Diagnostiskt Centrum (DC), Sweden's first specialized cancer diagnosis center, was established at Kristianstad General Hospital in 2012 as a model for reducing the time taken to diagnose cancer in primary care patients with diffuse, non-organ specific symptoms. If it is successful, the DC model could be rolled out to other areas of Sweden. This study by the Center for Primary Health Care Research in Malmö, Sweden and Regionalt cancercentrum syd will investigate whether the DC process reduces the time from (1) the point when the patient first contacts his/her primary care center with symptoms to (2) the point when he/she is informed about his/her diagnosis (of cancer or another disease). This will be achieved by comparison with matched control patients with suspected cancer who will be referred to Helsingborg General Hospital for further investigation according to existing diagnostic procedures. Various outcome measures will be investigated, and patients' experiences of the DC process will be assessed using a tailored questionnaire. In addition, the DC model will be subjected to health economics analysis.

Clinical Evaluation of a New Cancer Diagnosis Center at Kristianstad General Hospital, Sweden

Serum inflammatory cytokine levels will be compared between patients diagnosed with cancer and patients not diagnosed with cancer (Diagnostiskt Centrum patients only).

Serum EGF receptor levels will be compared between patients diagnosed with cancer and patients not diagnosed with cancer (Diagnostiskt Centrum patients only).

Plasma microRNA levels will be compared between patients diagnosed with cancer and patients not diagnosed with cancer (Diagnostiskt Centrum patients only).

Telomere length (measured using whole-blood samples) will be compared between patients diagnosed with cancer and patients not diagnosed with cancer (Diagnostiskt Centrum patients only).

The time from the point at which the patient first makes contact with his/her primary care center to the point when he/she is given his/her diagnosis. This comprises two elements: (1) investigation in primary care and (2) investigation at Diagnostiskt Centrum/Helsingborg General Hospital. These two elements will be investigated as secondary outcome measures.

Region Skane

Neoplasms

Symptoms and General Pathology

All Conditions

Neoplasm Metastasis

Pain

Neoplastic Processes

The radiation technique used for each patient will be based on local clinical practices and on number of vertebae to treat between 1\*8 Gy; 5\*4 Gy and 10\*3 Gy

External radiotherapy

Percutaneous vertebroplasty

Bertrand BR RICHIOUD, MD

The purpose of this study is to evaluate cost-utility analysis in order to provide recommendations to French decision-makers between vertebroplasty and radiation therapy in Bone spine metastases. Indeed, radiation therapy is often advocated a systematic way. The object of this study would be to expand the use of vertebroplasty.

Moreover, this study assess to the strategy impact on the pain control reduction and functional preservation. In fact, analgesic effect is achieved differently depending on the procedure used.Eligible patients will be recruited and registered consecutively. Patients will be randomly,

This is a health-economic multicenter, prospective, randomized with stratification according to number of vertebrae to treat (1-3 vertebrae vs 4-6 vertebrae) and center :

* Arm A: Percutaneous vertebroplasty
* Arm B: External radiotherapy

This is an open-label study. The expected total study period is 2.5 years (enrolment: 2 years, patient follow-up: 6 months). A total number of 304 patients with spine metastases will be recruited (152 patients/arm).

Bone is the most common site for metastasis. In breast and prostate cancers, 70% of patients dying of their cancer have evidence of metastatic bone disease \[Coleman, 2006\]. Depending on their localization, bone metastases can have debilitating consequences resulting in considerable morbidity and complex demands on health care resources. Bone spine metastases are the most frequent site observed in patients with cancer of the lung, prostate, breast and hemopoetic organs. The occurrence of spinal metastases in patients with advanced cancer can cause significant morbidity, with pain and/or neurological deficit adversely affecting the patients' quality of life.

Interventional radiology takes a large place in the treatment of bone metastases. Currently, vertebroplasty appears as the most satisfactory technique for stabilization of spine metastases offering a significant improvement of the quality of life. The analgesic effect is achieved very rapidly, i.e. usually within 24 hours post-procedure. Based on several publications, around 90% of patients reported rapid pain relief following vertebroplasty with 60 to 70% of complete pain relief \[Mendel, 2009\].

Radiotherapy also plays a very important role in the palliative treatment of the metastatic bone. Radiotherapy is effective and well tolerated. A reduction of the pain is noticed for 70 to 80 % of the patients and begins one or two weeks after the treatment. In all, the radiotherapy increases the quality of life of the patients and can reduce the intake of analgesics \[Lutz, 2011\].

In a lot of cases, vertebroplasty or radiotherapy can both be performed for a same painful patient (the National Institute for Health and Clinical Excellence (NICE) approved the use of vertebroplasty for patients with spinal metastases in November 2008). Radiotherapy remains the gold-standard treatment. However, vertebroplasty could be less costly and more effective compare to radiotherapy. In fact, the superiority of vertebroplasty has been demonstrated at least in the acute post-therapeutic period with (i) more rapid autonomy recovery, (ii) reduction of antalgic intakes, and potentially less side-effects.

Health Economics Evaluation of Percutaneous Vertebroplasty Compared to Radiation Therapy in Patients With Painful Spine Metastases.

To perform a cost-utility analysis in order to provide recommendations to French decision-makers on the treatment of patients with painful spine metastases.

Incremental cost-effectiveness ratio expressed in cost per quality adjusted life year (QALY) gained

Cost-assessment, Quality of life (EQ-5D) Quality adjusted life year,

Centre Leon Berard

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Infections

Prostatic Neoplasms

Communicable Diseases

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Central Nervous System Depressants

All Drugs and Chemicals

Anesthetics

Anesthetics, Local

LATP prostate biopsy performed with an average of 12 biopsy cores in 6 sectors depending on prostate size, plus typically 4 target cores per MRI lesion, using an ultrasound probe-mounted LATP needle guidance device (e.g. the "Precision-Point" access system, or BK UA1232, or any other which is used in a virtually identical fashion).

TRUS prostate biopsy performed according to each hospital's standard practice, with an average of 12 biopsy cores, in two sectors with additional target pots (typically 4 target cores per MRI lesion).

Prostate biopsy via either the Transrectal route (comparator) or Transperineal route (experimental), each under local anaesthetic.

Prostate biopsy

Roxanne Williams

Richard Bryant, MBChB, PhD

Alastair Lamb, MBChB, PhD

Richard Bryant

Alastair Lamb

The TRANSLATE randomised controlled trial aims to evaluate local anaesthetic transperineal biopsy (LATP) versus transrectal ultrasound-guided (TRUS) prostate biopsy, in the evaluation of previously biopsy-naive men being investigated for clinically significant prostate cancer (on the basis of an elevated age-specific PSA, or abnormal digital rectal examination, or MRI-visible lesion). Men under investigation for possible prostate cancer and recruited to TRANSLATE will be randomised to receive either an LATP or TRUS prostate biopsy, with the primary outcome measure being detection of clinically significant prostate cancer (defined as any Gleason pattern 4 disease, i.e. any Gleason Grade Group \>=2 disease). Secondary outcome measures include infection, other complications, tolerability, rate of re-biopsy, detection of clinically insignificant prostate cancer, and a full health economics evaluation.

100,000 men each year in the United Kingdom are referred for investigation for possible prostate cancer based on an abnormal digital rectal examination of the prostate and/or an elevated age-specific PSA blood test. These men may be offered a pre-biopsy MRI scan, followed by a prostate biopsy. Prostate biopsies have typically been taken via an ultrasound-guided transrectal approach (TRUS) under local anaesthetic in the clinic for several decades. However, local anaesthetic transperineal biopsy (LATP) has been pioneered in recent years, in order to sample the prostate gland via the perineum in the clinic, with the potential advantage that the transperineal approach to sampling reduces the risk of serious infection, and improves the sampling of the prostate gland (thus increasing the cancer detection), whilst avoiding the need for general anaesthetic in the operating theatre (as was the case for historical template prostate biopsies).

The way in which urologists take biopsies for possible prostate has started to vary across the United Kingdom; however, no level 1 evidence exists as to which method is best - both in terms of detecting clinically significant prostate cancer, and in terms of the occurrence of serious infection and other common side-effects of the biopsy process, along with patient tolerability, re-biopsy rate, and cost-effectiveness.

The TRANSLATE study aims to recruit 1042 men from at least 9 large Urology departments from United Kingdom Hospitals. These men will be under investigation for possible prostate cancer, and will not have received a prostate biopsy previously.

All men eligible for the study will have had a pre-biopsy MRI scan as part of the investigation for possible prostate cancer. After obtaining informed consent they will be randomised to either a TRUS biopsy or an LATP biopsy. Following the biopsy procedure, the study team will follow up the men in order to determine the rate of detection of clinically significant prostate cancer (primary outcome) in each biopsy group. The study team will also gather information (as secondary outcomes) on the occurrence of any post biopsy infections, and other patient reported biopsy-related complications such as bleeding, bruising, pain, and loss of erections and sexual function. Additionally, the study team will record any subsequent prostate biopsy procedures, which might be recommended if the first prostate biopsy has produced a possible 'false negative' result, where clinicians have concerns that the prostate biopsy result is inconsistent with the pre-biopsy MRI scan result and where there are concerns that a 'clinically significant' prostate cancer may have been under-detected. Data will be collected before the biopsy (baseline), immediately after the biopsy, and then at 7 days, 35 days and 4 months following the biopsy.

The total length of the study is 31 months (to include trial setup phase, recruitment phase, data analysis and write-up of reports and publications). Recruitment of patients will last for 15 months. There will be a formal 'stop/go' review at the end of month 12 (i.e. after a full 6 months of recruitment) in order to ensure that a minimum of 140 patients has been randomised, and that at least 4 centres have been opened to recruitment. If the study team meets the 'stop/go' recruitment target, the trial will continue to recruit for a further 9 months. Data from all patients recruited in the 15 month period will be included in the final analysis.

The TRANSLATE Trial

A Randomised Controlled Trial Comparing TRANSrectal Biopsy Versus Local Anaethetic Transperineal Biopsy in Evaluation (TRANSLATE) of Men With Potential Clinically Significant Prostate Cancer

Clinically significant prostate cancer (as defined by the presence of Gleason Grade Group ≥2 prostate cancer, i.e. any Gleason pattern ≥4 disease).

Post-biopsy infection - patient questionnaire reporting.

Histology reporting of grading of biopsy samples as per local reporting practices.

National Institute for Health Research, United Kingdom

University of Oxford

Rare Diseases

Uterine Cervical Neoplasms

Uterine Cervical Dysplasia

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Precancerous Conditions

Cervical Intraepithelial Neoplasia

A midwife tries to contact the woman by telephone and offer her an appointment for a PAP-smear

No intervention other than what is routine in the screening program

Midwifes at 72 antenatal care units in West region of Sweden receive lists with names and telephone numbers on women who have no record of screening during two screening rounds (6 - 10 years depending on age). The midwife will make up to ten attempts to reach each woman and is instructed to use no more than 30 minutes on this. If the midwife get in touch with the woman she will encourage participation in regular screening (run by midwives in Sweden) and help the woman to get an appointment.

Telephone arm

Women receive an offer to order a vaginal self test for HPV. The woman can return a coupon in a postage free envelope and she will receive a self testing kit (dry method) within a couple of days. She will return the test in another postage free envelope. A reminder will be sent to women who order a test but do not return it.

Self-test arm

Björn Strander, MD, PhD

Women who don't participate in Swedish cytology screening program are a minority of about 10%, but constitute the majority of those who acquire cervical cancer. Over 50 000 women in the Västra Götalandregion have abstained from participation in the program for at least 2 screening rounds (6 - 10 years, depending om age). We plan to test two promising strategies to increase participation. In a study of two different health policies women who have defaulted are randomised to receiving a telephone call from a midwife, receive an offer of a self-test for HPV or being included in a control group. This is an effectiveness study that should give an answer how participation could be increased and give the basis for a calculation of the costs involved, before decisions can be made about implementing either intervention.

Background

Cervical cancer today is considered as a disease that to a very large extent is preventable. In Sweden cytological screening has been ongoing since the 60:s and this has made cervical cancer a rare disease. Several new, but costly, methods like HPV-testing and vaccination has been claimed to further reduce cancer incidence, but this has not been scientifically proven so far. A recent audit of the Swedish screening program (Andrae 2008) found that the foremost risk factor for cervical cancer in the context of the program was non participation. Women who do participate are well protected from cervical cancer.

A Swedish study evaluating different strategies to increase participation found telephone contact with defaulters to be the superior intervention (Eaker 2004). This study was done in a region of Sweden with lower coverage (Sparén 2007) and less emphasis on efforts to increase participation. A study from Kalmar, Sweden, with high coverage did not find an extended yield to requests from non-participating women to be cost effective (Oscarsson 2007). Self testing for HPV has been advocated as an effective method and there is a kit commercially available (Stenvall 2007). The procedure is used as a routine in Uppsala county and marketed to other counties.

Aim To study two possible interventions to increase participation

Design Randomised controlled trials of two interventions and a control arm

Hypothesis

Intervention with a) supportive telephone contact, by a midwife, with women who do not have a smear registered for two screening rounds will increase participation, increase uptake of precancerous lesions (CIN2+) and is cost effective. b) selftesting for oncogenic papillomavirus (HPV) will increase participation and is cost effective.

Method: selection of study base

Selection was done by random among women aged 29 - 63 who did not have a pap-smear registered within the two recent screening rounds. Women who were excluded from invitation due to total hysterectomy and women who could be identified as have immigrated into the region under the period were excluded before randomisation. July 1 2008 there was 52362 women who fulfilled the first criteria (before exclusions) identified through the Register for Prevention of Cervical Cancer in West Sweden. 8800 selected women will be included and randomised to one of three arms with the distribution 5:1:5

Methods: Intervention Arm A: 4000 randomised women fulfilling inclusion criteria receive a letter informing them they will be contacted by a midwife by phone, to be offered an appointment to take a smear. They can at that stage decline such contact or if they wish return contact information (telephone number). A week later the women who have not declined will be called by a midwife and offered an appointment for taking a smear. Abnormal smear will be followed up with referral to a gynecologist in concordance with normal screening routine.

Arm B: 800 women will be sent an offer of HPV-self sampling (Aprovix, Uppsala, Sweden). By regular mail the woman can order a test kit, and return this to the laboratory after sampling. The samples will be tested with Hybrid Capture II for high risk HPV. A negative result will be communicated to the women. A positive result will be sent to the gynecological clinic responsible for the work up of abnormal cytological screening smears in the area were the woman lives. The afflicted woman will get information from the clinic and an appointment for colposcopy and cytology. Further investigation will be conducted as clinical routine. Reminders will be sent to women who have ordered the kit and not returned any sample. In order to evaluate the effect of a primary reminder women who have not responded to the primary offer within 60 days will receive a reminder.

Arm C (controls) 4000 women will be controls. No specific action will be taken within the study outside routine in the screening program (yearly written reminder when smears are not found in the database)

Methods: Data collection All data about cytology, colposcopy with biopsies and treatment for CIN are registered as a routine in the West Sweden Registry for Cervical Cancer Prevention and data will be extracted from that registry. Data about HPV-testing will be transferred to this registry from the Aprovix laboratory in Uppsala. Man-time needed and costs for material and analyses for the different interventions will be registered as base for health economic assessments.

Primary outcomes: Frequency of testing (cytology in arm A and C and HPV-test in arm B). Frequency of further assessment of abnormal tests (all arms).

Secondary outcomes: (Arm A vs arm C) Frequency of abnormal smears. Frequency of treated CIN, (CIN1, CIN2 and CIN3, grouped as low grade (CIN1) and high grade (CIN2, CIN3, AIS and invasive cancer). Number of invasive cancers and FIGO stadium. Cost of interventions. Cost per CIN2+ found. The study is powered to find a 30% difference in primary outcome based on an expected 20% participation rate in the control group with 80% power at a significance level of 5% for both interventions (A and B compared with C). An expected rate of abnormal smears of 7% among these women with no smear recorded 6 or more years will give a 80% power to find a 60% relative difference in number of abnormal smears (RR=1,6) when intervention arm A is compared with the controls in arm C.

The results from work up of abnormal tests in arm A will be considered representative for arm B as well, given the same level of abnormality.

The cost per participant and per biopsy with CIN found will be calculated. The cost per found and treated high grade CIN will be compared with a reference of estimated €3500 (preliminary figure) per CIN2+ that is eradicated.

Methods:Statistical analysis All analysis will be based on intention to treat. Pearson's Chi2 and Fischers exact test will be used to compare distribution of categorical variables between the groups. One way variances will be used to test differences of means between groups for continuous variables. The cumulated probability for outcome vs. follow up time will be calculated with Kaplan-Meier analysis. Multiple Cox regression will be used to determine relative risks. 95 % confidence intervals will be used throughout and level of significance will be calculated two sided as 5%

Randomized Controlled Trial to Study Interventions to Increase Participation in Cervical Cancer Screening Program

Vastra Gotaland Region

Assar Gabrielsson Cancer Foundation, Sweden

Göteborg University

Gland and Hormone Related Diseases

Thyroid Neoplasms

Thyroid Diseases

Endocrine System Diseases

Endocrine Gland Neoplasms

Head and Neck Neoplasms

different care management pathways, including thyroidectomy, iode 131, hormonal treatment and type of follow up

care management pathways

Nadège Costa, PhD

The incidence of Thyroid Cancer (TC) has increased over the last thirty years, in France and worldwide. This increase is mainly due to good prognosis microPapillary TC (mPTC). Sixty percent of diagnosed cancers are considered as over-diagnosed, leading to an over-treatment of these cases. The increase of diagnosis of mPTC and its treatment inevitably leads to an increase of medical resources consumption and corresponding costs.

The primary aim of this study is to estimate the cost related to different care management pathway of TC patient during a lifetime period using a multi-state Markov model.

This is a retrospective, observational population based cohort study, using data from a cohort study of TC patients implemented by the ONCOMIP network which initially aimed to perform an audit of clinical practices for the management of TC, and from database of the French social health insurance of Midi-Pyrenees region to calculate observed costs of TC management during 24 months.

Estimation of Economic Consequences Linked With Different Care Management Pathways of Differentiated Thyroid Cancers

Estimation of Economic Consequences Linked With Different Care Management Pathways of Differentiated Thyroid Cancers : Involvement of Overtreatment

estimate the cost related to the different management pathways of TC patient during a lifetime period using a multi-state Markov model

University Hospital, Toulouse

Behaviors and Mental Disorders

Skin and Connective Tissue Diseases

Anxiety Disorders

Melanoma

Skin Neoplasms

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Diseases

Quality of Life

Neuroendocrine Tumor

Neuroepithelioma

Clinical surveillance standard of care with addition of 2D or 3D Melanoma Surveillance Photography and digital dermoscopy.

Clinical surveillance standard of care without Melanoma Surveillance Photography.

Total body imaging using 2D or 3D Melanoma Surveillance Photography plus digital dermoscopy.

2D or 3D Melanoma Surveillance Photography

Victoria Mar

This randomised controlled trial will investigate the role of melanoma surveillance photography (MSP) in the surveillance of patients at high or ultra-high risk of melanoma. MSP is a comprehensive method of melanoma monitoring which includes total body photography and digital dermoscopy which is performed at prescribed intervals. The study will test whether participants under surveillance with MSP have less unnecessary biopsies (false positives) compared to those without MSP. Participants will be Australian residents with a new diagnosis of primary melanoma, who have multiple naevi and are at high or ultra-high risk of developing melanoma. Participants will be randomised 1:1 to either groups.

It is hypothesised that those randomised to surveillance with MSP will have better patient outcomes. Improved diagnostic performance as measured by the number of unnecessary biopsies will be the primary outcome measure.

The primary aim is to test whether melanoma surveillance with MSP, comprising either 2D or 3D TBP tagged with digital dermoscopy, compared to clinical surveillance without MSP, results in improved diagnostic performance, specifically reduced number of unnecessary biopsies (i.e. false positives due to an excision or biopsy of a lesion being performed to diagnose melanoma and that lesion being identified on pathology as benign), in high (and very high) risk individuals whose risk is contributed to by high naevus counts.

The secondary aims are to:

1. Evaluate whether MSP:

   1. Results in improved sensitivity of doctors' diagnosis of melanoma (i.e. reduction in false negatives)
   2. Improves health-related quality of life, patient satisfaction, and reduces patient anxiety
   3. Reduces costs to patients and health care system
2. Evaluate the safety and acceptability of MSP
3. Evaluate benefit of MSP in high risk patients prior to a primary melanoma diagnosis (Sub-study 1)
4. Evaluate diagnostic performance of tele-dermatology compared to en-face clinical visits (Sub-study 2).

Investigators hypothesise that for ultra-high and high risk patients with multiple naevi, clinical surveillance with melanoma surveillance photography (compared to without MSP) will lead to better patient outcomes, in particular a reduction in the number of unnecessary biopsies (i.e. false positives) as a measure of diagnostic performance. Secondary hypotheses include that for ultra-high, and high risk patients with multiple naevi, clinical surveillance with MSP (compared to without MSP) will lead to:

1. Reduction in the number of misclassified melanoma malignancies (i.e. false negatives);
2. Reduction in the number of misclassified melanocytic and keratinocyte lesions combined;
3. Improved quality of life; and
4. Favourable health economic outcomes.

The trial is an open-label, multi-site, parallel-arm randomised controlled trial. Participants meeting the eligibility criteria will be randomised 1:1 to either standard care or the intervention arm. Randomisation will be 1:1 to either Intervention or Control group stratified by high/ultra-high risk of 2nd primary melanoma, sex, 2D/3D imaging, GP/Dermatologist.

Melanoma Surveillance Photography (MSP) to Improve Early Detection of Melanoma in Ultra-high and High Risk Patients

To estimate the benefit of MSP in high risk patients prior to a melanoma diagnosis, amongst participants who would have been classified as 'high risk' at the time of their primary melanoma, this sub-study will compare:

i) Breslow thickness of the primary melanoma at entry into this trial, and ii) Biopsy rates prior to diagnosis

Approximately 100 paired sets of 3D surveillance and digital dermoscopy images (baseline and follow-up) taken from patients in the intervention arm, will be sent to 10 participating study doctors (both GPs and dermatologists; all 100 pairs sent to all 10 doctors) for teledermatology assessment. The study doctors will assess the images with respect to whether they have a melonama present or not. Images will be selected randomly from amongst patients accrued to the main study for this telediagnosis validation study. Approximately 30% of these will include an image of a melanoma confirmed by histopathology (gold standard) during the trial. This substudy will not affect patient care but will assess diagnostic performance (sensitivity and specificity) in the teledermatology setting compared to the en-face clinical setting in order to validate the use of telediagnosis in routine care.

The primary outcome is the diagnostic performance of surveillance for melanoma, expressed as the number of false positive biopsies per patient over a 24-month period.

Standard health economic cost-effectiveness measures.

Assessment of Quality of Life (AQOL-8D) questionnaire for calculation of quality-adjusted life years (QALYs). Minimum score per each of 8 questions is 1; maximum score is 5, where higher score represents worse outcomes. Scores may be aggregated to provide an overall index of the health state utility per participant, where higher scores indicate worse quality of life outcomes.

European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30), Fear of Cancer Recurrence - short form (FCR4) and a purpose-designed patient acceptability scale will be utilised to synthesise a single endpoint measure for patient anxiety. Value range is 0 to 100, where higher values represent greater anxiety (worse outcomes).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Clinical Evaluation of a New Cancer Diagnosis Center at Kristianstad General Hospital, Sweden	NCT01709539	Cancer	Diagnostiskt Ce...	18 Years -	Region Skane
Health Economics Evaluation of Percutaneous Vertebroplasty Compared to Radiation Therapy in Patients With Painful Spine Metastases.	NCT02174107	Spine Metastase...	External radiot... Percutaneous ve...	18 Years -	Centre Leon Berard
Clinical Evaluation of a New Cancer Diagnosis Center at Kristianstad General Hospital, Sweden	NCT01709539	Cancer	Diagnostiskt Ce...	18 Years -	Region Skane
The TRANSLATE Trial	NCT05179694	Prostate Cancer	Prostate biopsy	18 Years -	University of Oxford
Randomized Controlled Trial to Study Interventions to Increase Participation in Cervical Cancer Screening Program	NCT01029990	Cervical Intrae...	Telephone arm Self-test arm	29 Years - 63 Years	Göteborg University
Randomized Controlled Trial to Study Interventions to Increase Participation in Cervical Cancer Screening Program	NCT01029990	Cervical Intrae...	Telephone arm Self-test arm	29 Years - 63 Years	Göteborg University
Estimation of Economic Consequences Linked With Different Care Management Pathways of Differentiated Thyroid Cancers	NCT03787121	Thyroid Cancer	care management...	18 Years -	University Hospital, Toulouse
Melanoma Surveillance Photography (MSP) to Improve Early Detection of Melanoma in Ultra-high and High Risk Patients	NCT04385732	Melanoma Skin Cancer Anxiety and Fea...	2D or 3D Melano...	18 Years -	Melanoma and Skin Cancer Trials Limited

Spots Global Cancer Trial Database for health economics