NCT04385732Fut, nem toboroz
Melanoma Surveillance Photography (MSP) to Improve Early Detection of Melanoma in Ultra-high and High Risk Patients
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. máj. 8.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Fut, nem toboroz
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 670 (tényleges)
- Első benyújtás
- 2020. ápr. 1.
- Kezdés
- 2021. márc. 3.
- Elsődleges befejezés
- 2025. máj.
- Fő szponzor
- Melanoma and Skin Cancer Trials Limited
- Betegségek
- Melanóma
- NCT-szám
- NCT04385732
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Bevont résztvevők: 670
- 2021. márc. 3. és az elsődleges befejezés (2025. máj.) között
- 12 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
Ki nem vehet részt
Szó szerint a(z) ClinicalTrials.gov forrásból, témák szerint csoportosítva. Hogy ki vehet részt, azt csak a vizsgálat csapata dönti el.
Korábbi kezelés
- Previously under active surveillance with TBP (active surveillance referring to TBP images being used for melanoma surveillance Stage IV metastatic melanoma
Más betegség
- Participation in another clinical trial or study involving MSP
- Note:
- A past history of other cancers is not an exclusion criteria.
- *These eligibility criteria cannot be assessed by the cancer registry. These criteria will be assessed by the study team and/or referring doctor.
Egyéb
- Patients will be excluded from the study for ANY of the following reasons:
- Stage IV metastatic melanoma
- Ocular melanoma, mucosal melanoma
Kiket keres a vizsgálat
- Patients may be included in the study if they meet ALL of the following criteria:
- Aged 18 years or older at date of diagnosis
- Within 24 months (2 years) of the date of diagnosis when attending Screening \& Baseline Visit: where date of diagnosis refers to the date on the pathology report that provides histological confirmation of primary cutaneous melanoma (insitu or invasive)
- Able to provide informed consent, complete questionnaires, and attend trial site for MSP*
- Appropriate for TBP referral
- High/very high risk of subsequent primary melanoma (see risk assessment tool, Appendix IV)*
- Multiple naevi, as "some" or "many" naevi on pictogram below at Screening \& Baseline visit.
- Not previously under active surveillance (at least yearly) with TBP for melanoma surveillance (see inclusion criteria 9)
- Living in Australia and not planning to move overseas within the next 3 years
- Participants that meet all eligibility criteria but have previously been under active surveillance with TBP for at least the previous 2 years meet exclusion critierion 1, in which case they are ineligible for the main study and eligible for sub-study 1 only.
- Active surveillance with TBP refers to TBP images having been taken AND used for melanoma surveillance. As such, if a patient had TBP but these images were not used for melanoma surveillance (i.e. not used by clinicians to monitor a patient's skin), then surveillance is not considered active and the patient would still be eligible for the main study (as well as sub-study 1).
- Patients need to have had at least annual surveillance over the past 2 years (at least) to be eligible for sub-study 1 (note that this refers to annual skin surveillance not annual TBP images being taken) (i.e. do not meet inclusion criteria 7 are eligible for sub-study 1)
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (12)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Bendigo Cancer Centre Research Unit, Bendigo Health | Bendigo | Ausztrália | Ismeretlen állapot |
| Diamantina Institute, University of Queensland | Brisbane | Ausztrália | Ismeretlen állapot |
| FNQH Cairns Skin Cancer Centre | Cairns | Ausztrália | Ismeretlen állapot |
| Royal Prince Alfred Hospital | Camperdown | Ausztrália | Ismeretlen állapot |
| Skin Health Institute | Carlton | Ausztrália | Ismeretlen állapot |
| Phillip Island Health Hub, Bass Coast Health | Cowes | Ausztrália | Ismeretlen állapot |
| Victorian Melanoma Service, Alfred Health | Melbourne | Ausztrália | Ismeretlen állapot |
| Newcastle Skin Check | Newcastle | Ausztrália | Ismeretlen állapot |
| Dermatology Clinical Trials Unit, Westmead Hospital | Sydney | Ausztrália | Ismeretlen állapot |
| Skin Repair Skin Cancer Clinic, Townsville | Townsville | Ausztrália | Ismeretlen állapot |
| Melanoma Institute Australia | Wollstonecraft | Ausztrália | Ismeretlen állapot |
| Wonthaggi Hospital, Bass Coast Health | Wonthaggi | Ausztrália | Ismeretlen állapot |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.