- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT05161585
Evaluation of Circulating Tumor DNA Guided Surveillance Strategy of Stage III Colorectal Cancer: an Open, Prospective, Randomized Controlled Cohort Study
Panoramica dello studio
Stato
Intervento / Trattamento
Tipo di studio
Iscrizione (Anticipato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Junjie Peng, MD, PhD
- Numero di telefono: 86-18017317122
- Email: pengjj67@hotmail.com
Backup dei contatti dello studio
- Nome: Yaqi Li
- Numero di telefono: 86-15902194450
- Email: yaqi702@hotmail.com
Luoghi di studio
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Shanghai
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Shanghai, Shanghai, Cina, 200032
- Reclutamento
- Fudan University Shanghai Cancer Center
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Contatto:
- Junjie Peng, MD, PhD
- Numero di telefono: 86-18017317122
- Email: pengjj67@hotmail.com
-
Contatto:
- Yaqi Li, MD, PhD
- Numero di telefono: 86-15902194450
- Email: yaqili702@hotmail.com
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Diagnostico
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: 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.
|
Nessun intervento: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Sensitivity of postoperative ctDNA in monitoring recurrence and metastasis
Lasso di tempo: Up to 60 months.
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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
Lasso di tempo: 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
Lasso di tempo: Up to 60 months.
|
True positive+True negative/sample size
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Up to 60 months.
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Secondary resection rate
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
ctDNA-disease free survival (DFS)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Up to 60 months.
|
The difference between ctDNA-DFS and CT-DFS
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Up to 60 months.
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sopravvivenza globale (OS)
Lasso di tempo: Dalla data di randomizzazione fino alla data della prima data documentata di morte per qualsiasi causa, valutata fino a 60 mesi.
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Sopravvivenza globale dei pazienti inclusi
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Dalla data di randomizzazione fino alla data della prima data documentata di morte per qualsiasi causa, valutata fino a 60 mesi.
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ctDNA clearance rate
Lasso di tempo: Up to 60 months.
|
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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Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- ctDNA- phaseIIICRC
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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Bispebjerg HospitalSygehus LillebaeltAttivo, non reclutanteDanni al DNA | Raggi ultravioletti; Infortunio | Formazione dell'addotto del DNA | Danno al DNA, indotto da radiazioniDanimarca
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University of ZagrebUniversity of Split, School of MedicineReclutamento
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University of Split, School of MedicineReclutamento
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University of Colorado, BoulderNational Cancer Institute (NCI); National Institutes of Health (NIH)CompletatoMetilazione del DNAStati Uniti
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Cancer Council VictoriaCompletatoMetilazione del DNA
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National Center for Tumor Diseases, HeidelbergAstraZeneca; German Cancer Research Center; PharmaMarCompletatoTumori con deficit di riparazione del DNAGermania
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Fudan UniversityReclutamento
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Chen Zi-JiangChinese Academy of SciencesCompletato
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Tahitian Noni International, Inc.University of Illinois at ChicagoCompletato
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Loma Linda UniversityRitiratoTendinopatia della cuffia dei rotatoriStati Uniti
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Milton S. Hershey Medical CenterNational Heart, Lung, and Blood Institute (NHLBI)ReclutamentoComplicazione della linea centrale | Infezione della linea centraleStati Uniti
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The First Hospital of Jilin UniversityGeneplus-Beijing Co. Ltd.Reclutamento