- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT05161585
Evaluation of Circulating Tumor DNA Guided Surveillance Strategy of Stage III Colorectal Cancer: an Open, Prospective, Randomized Controlled Cohort Study
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Junjie Peng, MD, PhD
- Telefonnummer: 86-18017317122
- E-mail: pengjj67@hotmail.com
Undersøgelse Kontakt Backup
- Navn: Yaqi Li
- Telefonnummer: 86-15902194450
- E-mail: yaqi702@hotmail.com
Studiesteder
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Shanghai
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Shanghai, Shanghai, Kina, 200032
- Rekruttering
- Fudan University Shanghai Cancer Center
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Kontakt:
- Junjie Peng, MD, PhD
- Telefonnummer: 86-18017317122
- E-mail: pengjj67@hotmail.com
-
Kontakt:
- Yaqi Li, MD, PhD
- Telefonnummer: 86-15902194450
- E-mail: yaqili702@hotmail.com
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Diagnostisk
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: 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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Ingen indgriben: 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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Sensitivity of postoperative ctDNA in monitoring recurrence and metastasis
Tidsramme: 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
Tidsramme: 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
Tidsramme: Up to 60 months.
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True positive+True negative/sample size
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Up to 60 months.
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Secondary resection rate
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
ctDNA-disease free survival (DFS)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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samlet overlevelse (OS)
Tidsramme: Fra datoen for randomisering til datoen for første dokumenterede dødsdato uanset årsag, vurderet op til 60 måneder.
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Samlet overlevelse af inkluderede patienter
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Fra datoen for randomisering til datoen for første dokumenterede dødsdato uanset årsag, vurderet op til 60 måneder.
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ctDNA clearance rate
Tidsramme: 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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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- ctDNA- phaseIIICRC
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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Kliniske forsøg med Cirkulerende tumor-DNA
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Fudan UniversityRekruttering
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Foundation MedicineJohns Hopkins University; Memorial Sloan Kettering Cancer Center; University... og andre samarbejdspartnereAfsluttetNeoplasmer | Kræft | Cirkulerende tumor-DNA | Genomisk test | Genomiske ændringerForenede Stater
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TILT Biotherapeutics Ltd.Rekruttering
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Zhiyong YuUkendtBrystkræft | Cirkulerende tumor-DNA | Neoadjuverende kemoterapiKina
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Sun Yat-sen UniversityUkendt
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Shanghai Zhongshan HospitalIkke rekrutterer endnuNeoplasmer i maven | Cirkulerende tumor-DNA
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