NOAC9 - Circulating Tumor DNA Guided Follow-Up in Anal Cancer
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: AMR B: HPV positive ctDNA guided imaging in follow-up.
- Кому может быть актуально
- Состояния в реестре: Anal Cancer. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Дания, Финляндия, Норвегия, Швеция
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
NOAC9 - A Phase II Randomised Nordic Anal Cancer Group Study on Circulating Tumor DNA Guided Follow-Up
Обзор
This study investigates if circulating tumor DNA can improve the detection of early treatment failure or recurrence in localized squamous cell carcinoma of the anus (SCCA) after curative chemoradiotherapy thereby increasing the potential for cure. This will be done by comparing the standard follow-up program with ctDNA guided imaging follow-up. Secondly, the aim is to establish early interventions against late morbidities.
Подробное описание
Squamous cell carcinoma of the anus (SCCA) is a rare disease with less than 200 new cases in Denmark and Sweden each year and approximately 100 new cases in Norway and Finland but with increasing incidence. Primary treatment is chemo-radiotherapy (CRT) comprising high dose IMRT based radiation therapy with combination chemotherapy of 5-FU and Cisplatin. Overall treatment response is good in small tumors, but less pronounced for high-risk tumors.
In absence of complete pathological response after CRT or local recurrence, patients are evaluated for. salvage surgery. The importance of R0 resection on overall survival has been described in several studies. It is suggested that early detection of treatment failure and recurrences increases the chance of possible curative surgery (R0-resection) and thereby overall survival.
A follow-up program has 3 purposes
1. To detect lack of complete response to primary treatment 2. Early detection of local or distant recurrences 3. Describing and managing late morbidity
Purpose:
The main purpose of this follow-up study is to investigate if circulating tumor tDNA can improve detection of early treatment failure or recurrences thereby assisting in increasing the potential for cure. Secondly, to provide evidence for use of imaging and third objective is to establish early intervention against late morbidities.
Вмешательства
- Диагностический тест AMR B: HPV positive ctDNA guided imaging in follow-up
Blood samples in follow-up positive for ctDNA leads to an extra PET-CT scan to detect early treatment failure
Первичные конечные точки
- Disease free survival [Срок оценки: after 2 years]
Вторичные конечные точки (11)
- Time between ctDNA detected and CT verified recurrences [Срок оценки: after 5 years]
- Rate of succesful salvage surgery [Срок оценки: after 5 years]
- Pattern of failure [Срок оценки: after 5 years]
- Disease free survival at 5 years follow-up [Срок оценки: after 5 years]
- The rate of distant failures [Срок оценки: after 5 years]
- Overall survival [Срок оценки: 5 years]
- Explorative analysis of total circulating free DNA (cfDNA) [Срок оценки: 5 years]
- ctDNA assays for HPV negative cases [Срок оценки: 5 years]
- Acute toxicity [Срок оценки: after 2 and 5 years]
- Late toxicity [Срок оценки: after 2 and 5 years]
- Health related quality of life [Срок оценки: after 2 and 5 years]
Критерии участия
Критерии включения
- Patients with SCCA eligible for definitive (chemo)radiotherapy
- ≥ 18 of years
- Written and oral consent
Критерии исключения
- Conditions that will contraindicate blood samples
- Conditions that will contraindicate a PET-CT scan.
- Potential lack of compliance to standard FU program and study participation.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Диагностика
Центры проведения
Норвегия · 4 центра
- Haukeland University Hospital — Bergen
- Oslo University Hospital — Oslo
- University Hospital of North Norway — Tromsø
- St. Olav's University Hospital — Trondheim
Швеция · 4 центра
- Sahlgrenska University Hospital — Gothenburg
- Skåne University Hospital Lund — Lund
- Karonlinska University Hospital — Stockholm
- Norrlands University Hospital — Umeå
Дания · 3 центра
- Department of Oncology Herlev and Gentofte Hospital — Herlev
- Department of Oncology, Vejle Hospital — Vejle
- Aarhus University Hospital — Aarhus
Финляндия · 2 центра
- Tampere University Hospital — Tampere
- Turku University Hospital — Turku
Идентификаторы
NCT: NCT05572801 · 82386