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- Klinische proef NCT05161585
Evaluation of Circulating Tumor DNA Guided Surveillance Strategy of Stage III Colorectal Cancer: an Open, Prospective, Randomized Controlled Cohort Study
Studie Overzicht
Toestand
Interventie / Behandeling
Studietype
Inschrijving (Verwacht)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Junjie Peng, MD, PhD
- Telefoonnummer: 86-18017317122
- E-mail: pengjj67@hotmail.com
Studie Contact Back-up
- Naam: Yaqi Li
- Telefoonnummer: 86-15902194450
- E-mail: yaqi702@hotmail.com
Studie Locaties
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Shanghai
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Shanghai, Shanghai, China, 200032
- Werving
- Fudan University Shanghai Cancer Center
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Contact:
- Junjie Peng, MD, PhD
- Telefoonnummer: 86-18017317122
- E-mail: pengjj67@hotmail.com
-
Contact:
- Yaqi Li, MD, PhD
- Telefoonnummer: 86-15902194450
- E-mail: yaqili702@hotmail.com
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-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Age ≥ 18 and ≤80 years old, regardless of gender;
- Personal status (PS) score as over 80 or Eastern Cooperative Oncology Group (ECOG) score as 0 ~ 2;
- Pathologically confirmed as stage III colorectal cancer;
- Radical operation performed ;
- With expected survival of more than 12 months;
- The subjects (or their legal representative / Guardian) must sign the informed consent form, indicating that they understand the purpose of the study, understand the necessary procedures of the study, and are willing to participate in the study.
Exclusion Criteria:
- Neoadjuvant therapy performed before operation;
- Blood transfusion performed during operation or within 2 weeks before operation;
- Incomplete baseline samples, including preoperative plasma samples, surgical tumor tissue samples and plasma samples 3-7 days after operation;
- Two consecutive test points missing or three plasma samples missing in total before a positive ctDNA time point
- Pregnant or lactating women who have fertility and do not take adequate contraceptive measures;
- Have a history of other malignant tumors within 5 years, except cured cervical carcinoma in situ or non melanoma skin cancer;
- Primary brain tumor or central nerve metastasis is not under control, with obvious intracranial hypertension or neuropsychiatric symptoms;
- Patients with the following serious or uncontrollable diseases: severe heart disease, the condition is still unstable after treatment, including myocardial infarction, congestive heart failure, unstable angina pectoris, pericardial effusion with obvious symptoms or unstable arrhythmia within 6 months before enrollment; definite neuropathy or psychosis, including dementia or seizures; severe or uncontrolled infection; active disseminated intravascular coagulation and obvious bleeding tendency;
- Significant impairment of important organ function;
- Other conditions in which the investigator believes that the patient should not participate in this trial.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Diagnostisch
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Experimenteel: ctDNA dynamic monitoring + routine postoperative follow-up
ctDNA is detected before operation, before chemotherapy, and then every three months for 2 years, 10 times in total. At the same time, routine postoperative follow-up is given. To be pointed out, after the completion of the adjuvant chemotherapy, if the ctDNA test indicates positive, patients will immediately perform chest, abdominal and pelvic CT and other imaging tests to determine whether there is recurrence /metastasis. If it is not confirmed, repeat the imaging review every two months, and continue to perform ctDNA test every three months. If the following ctDNA test is negative for two consecutive times, the above imaging reexamination will return to the routine follow-up frequency. In addition, during the follow-up, the following situations may occur: the imaging examination has found recurrence/metastasis, but the ctDNA test is still negative. At this time, the patient will be informed and treated in time of the recurrence/metastasis. |
ctDNA is detected before operation, before chemotherapy, and then every three months for 2 years, 10 times in total.
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Geen tussenkomst: routine postoperative follow-up
Only routine postoperative follow-up is given as follows: Physical examination and CEA were performed every 3-6 months for the first 2 years, every 6 months within the third to fifth year, and then annually.
Chest/abdominal/pelvis computed tomography was performed annually for up to 5 years, and colonoscopy was performed for proper patients the first year after treatment and repeated in the third year if no advanced adenoma was found and then every 5 years.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Sensitivity of postoperative ctDNA in monitoring recurrence and metastasis
Tijdsspanne: Up to 60 months.
|
Number of patients with ctDNA positive and imaging confirmed recurrence or metastasis / number of all imaging confirmed recurrence or metastasis
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Up to 60 months.
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Specificity of postoperative ctDNA in monitoring recurrence and metastasis
Tijdsspanne: Up to 60 months.
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Number of patients with ctDNA negative and no recurrence and metastasis confirmed by imaging / number of patients with no recurrence and metastasis confirmed by imaging
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Up to 60 months.
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Accuracy of postoperative ctDNA in monitoring recurrence and metastasis
Tijdsspanne: Up to 60 months.
|
True positive+True negative/sample size
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Up to 60 months.
|
Secondary resection rate
Tijdsspanne: Up to 60 months.
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The rate of R0 resection for recurrence or metastasis after surgery of the primary
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Up to 60 months.
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
ctDNA-disease free survival (DFS)
Tijdsspanne: Under ctDNA monitoring, from date of randomization until the date of first documented recurrence or date of death from any cause, whichever came first, assessed up to 60 months.
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Disease free survival time under ctDNA monitoring
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Under ctDNA monitoring, from date of randomization until the date of first documented recurrence or date of death from any cause, whichever came first, assessed up to 60 months.
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CT-DFS
Tijdsspanne: Under imaging monitoring, from date of randomization until the date of first documented recurrence or date of death from any cause, whichever came first, assessed up to 60 months.
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Disease free survival time under imaging monitoring
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Under imaging monitoring, from date of randomization until the date of first documented recurrence or date of death from any cause, whichever came first, assessed up to 60 months.
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△DFS
Tijdsspanne: Up to 60 months.
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The difference between ctDNA-DFS and CT-DFS
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Up to 60 months.
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algehele overleving (OS)
Tijdsspanne: Vanaf de datum van randomisatie tot de datum van de eerste gedocumenteerde datum van overlijden door welke oorzaak dan ook, beoordeeld tot 60 maanden.
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Totale overleving van geïncludeerde patiënten
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Vanaf de datum van randomisatie tot de datum van de eerste gedocumenteerde datum van overlijden door welke oorzaak dan ook, beoordeeld tot 60 maanden.
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ctDNA clearance rate
Tijdsspanne: Up to 60 months.
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The rate of ctDNA positive before chemotherapy that turns negative after adjuvant chemotherapy
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Up to 60 months.
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Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- ctDNA- phaseIIICRC
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op Circulerend tumor-DNA
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Fudan UniversityWerving
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Foundation MedicineJohns Hopkins University; Memorial Sloan Kettering Cancer Center; University of... en andere medewerkersVoltooidNeoplasmata | Kanker | Circulerend tumor-DNA | Genomische testen | Genomische veranderingenVerenigde Staten
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TILT Biotherapeutics Ltd.Werving
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Zhiyong YuOnbekendBorstkanker | Circulerend tumor-DNA | Neoadjuvante chemotherapieChina
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Samsung Medical CenterActief, niet wervendHER2-positieve borstkanker | Chemotherapie-effect | Circulerend tumor-DNAKorea, republiek van
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WeiWei XiaoHaplox Biotechnology Co., Ltd.WervingMinimale resterende ziekte | Circulerend tumor-DNA | Rectaal adenocarcinoom | Neoadjuvante chemoradiotherapieChina
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Sun Yat-sen UniversityOnbekend
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Poitiers University HospitalVoltooidEndometriumkanker | Circulerend tumor-DNAFrankrijk
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Shanghai Pulmonary Hospital, Shanghai, ChinaOnbekendCirculerend tumor-DNA | Geavanceerde NSCLC | Circulerende tumorcellen
Klinische onderzoeken op ctDNA dynamic monitoring
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Dana-Farber Cancer InstituteBrigham and Women's HospitalVoltooidKwaadaardige tumoren | Subcutane Tumoren | LymfekliertumorenVerenigde Staten
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University Medical Center Ho Chi Minh City (UMC)WervingMaagkanker | ctDNAVietnam
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Fudan UniversityGuangzhou Burning Rock Dx Co., Ltd.WervingGemetastaseerde colorectale kanker | Geen bewijs van ziektestatus | ctDNA-bewakingChina
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Universidad de AntofagastaWervingSchouder Impingement Syndroom | Schouder pijnChili
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University Hospital, Basel, SwitzerlandResearch Center for Clinical Neuroimmunology and Neuroscience BaselNog niet aan het werven
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The First Hospital of Jilin UniversityGeneplus-Beijing Co. Ltd.Werving
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Zhejiang UniversityNog niet aan het wervenEGF-R-positieve niet-kleincellige longkanker
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Azienda Ospedaliera Universitaria Integrata VeronaWervingPDAC - Ductaal adenocarcinoom van de pancreasItalië
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Hospices Civils de LyonWerving
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Germanna de Medeiros BarbosaVoltooidNeuromusculaire manifestaties