NCT06076811Toboroz
DANISH.MRD: Danish Assessment of Minimal Residual Disease by Liquid Biopsies
Danish Assessment of Minimal Residual Disease by Liquid Biopsies
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. febr. 4.
Rövid összefoglaló (regiszter, angolul)
Approximately two-thirds of all colorectal cancer patients undergo surgery with the aim of curing them. However, despite the surgery, 20-25% of them experience relapse. It is possible to reduce the risk of relapse with chemotherapy, but as chemotherapy is associated with significant side effects, it is only given to patients at high risk of relapse. Currently, the risk is assessed based on an examination of the removed tumor tissue. In a previous research project, blood samples were taken after patients' surgery and examined for the presence of circulating tumor DNA (ctDNA). When cancer cells in solid tumors die, they release DNA, which can be detected in the blood. DNA in the blood has a half-life of less than 2 hours, so if ctDNA is found in a blood sample taken, e.g., 14 days after surgery, the patient most likely still has cancer cells in their body. The results show that if a patient has ctDNA in their blood after surgery, the risk of relapse is high. The presence of ctDNA in the blood has the potential to be a better indicator of the risk of future relapse than the tumor examination used today. Therefore, ctDNA analysis has the potential to become a marker that will be used in the future clinical setting for monitoring colorectal cancer. The overall objective of this study is to confirm that ctDNA found in a blood sample after intended curative treatment for CRC is a marker of residual disease and risk of recurrence and is applicable in clinical practice.
- Állapot (regiszter)
- Toboroz
- Vizsgálattípus
- Megfigyeléses
- Résztvevők száma
- 1600 (tervezett)
- Első benyújtás
- 2023. okt. 4.
- Kezdés
- 2023. aug. 1.
- Elsődleges befejezés
- 2028. júl. 30.
- Fő szponzor
- University of Aarhus
- Betegségek
- Vastagbélrák
- NCT-szám
- NCT06076811
Mit vállalsz
- Vizsgálat típusa: Megfigyeléses
- Tervezett résztvevők: 1600
- 2023. aug. 1. és az elsődleges befejezés (2028. júl. 30.) között
- 10 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
- Not treated with adjuvant chemotherapy
- Treated with neoadjuvant chemo-radiation therapy.
Más betegség
- Hereditary colorectal cancer linked to familial colonic polyposis or Lynch syndrome.
- Inflammatory bowel disease (Crohn's disease or ulcerative colitis).
- Malignant colorectal polyps diagnosed after polypectomy.
- Synchronous colorectal and non-colorectal cancer diagnosed per operative (except skin cancer other than melanoma).
- Other cancers (excluding colorectal cancer or skin cancer other than melanoma) within 3 years from eligibility screening.
Egyéb
- Verified distant metastases.
- Patients who are unlikely to comply with the protocol (e.g., uncooperative attitude, inability to return for subsequent visits) and/or otherwise considered by the Investigator to be unlikely to complete the study.
- DANISH.MRD part II - Surveillance
- Patients who are unlikely to comply with the protocol (e.g., uncooperative attitude, inability to return for subsequent visits) and/or otherwise considered by the Investigator to be unlikely to complete the study.
Kiket keres a vizsgálat
- Colon or rectal cancer, clinical tumor stage I-III.
- Patient able to understand and sign written informed consent.
- Scheduled for curative-intent resectional surgery (including "compromised" curative resections).
- Participation in DANISH.MRD part I - Surgery.
- Colorectal cancer, UICC stage III.
- Has received curative-intent resection and is a candidate for adjuvant chemotherapy (3- or 6-months regime).
A regiszterben nem jelölt feltételek
- DANISH.MRD part I - Surgery
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (10)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Aalborg University Hospital | Aalborg | Dánia | Toboroz |
| Aarhus University Hospital | Aarhus | Dánia | Toboroz |
| Bispebjerg Hospital | Copenhagen | Dánia | Toboroz |
| Herlev Hospital | Herlev | Dánia | Toborzás még nem indult |
| Gødstrup Hospital | Herning | Dánia | Toboroz |
| Regional Hospital Horsens | Horsens | Dánia | Toboroz |
| Odense University Hospital | Odense | Dánia | Toboroz |
| Regional Hospital Randers | Randers | Dánia | Toboroz |
| Vejle Hospital | Vejle | Dánia | Toboroz |
| Regional Hospital Viborg | Viborg | Dánia | Toboroz |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.