NCT07136493Visszavonva
Circulating Tumor DNA Based Minimal Residual Disease Detection for Patients With Early-Stage Breast Cancer
Evaluation of Circulating Tumor DNA Based Minimal Residual Disease Detection in Early Stage Breast Cancer Patients: A Prospective Study
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. jún. 25.
Megadott ok: Funding This study has been closed at City of Hope at the request of the Sponsor due to delays and changes in study timeline.
Rövid összefoglaló (regiszter, angolul)
This clinical trial studies how well circulating tumor deoxyribonucleic acid (ctDNA) based minimal residual disease (MRD) detection works for patients with early-stage breast cancer. MRD refers to a very small number of tumor cells that remain in the body during or after treatment. ctDNA refers to small pieces of DNA that are released into a person's blood by tumor cells as they die. Management of patients after cancer surgery remains a clinical dilemma, particularly for cancer detected at earlier stages as many patients are cured by surgery alone. This results in very large clinical trials required to demonstrate a modest benefit from treatment. Using ctDNA MRD testing in early-stage breast cancer patients receiving standard treatment may help researchers identify groups that would benefit from additional therapy, leading to better outcomes.
- Állapot (regiszter)
- Visszavonva
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 0 (tényleges)
- Első benyújtás
- 2025. aug. 10.
- Kezdés
- 2026. máj. 12.
- Elsődleges befejezés
- 2026. jún. 16.
- Fő szponzor
- City of Hope Medical Center
- Betegségek
- Tripla negatív emlőrák
- NCT-szám
- NCT07136493
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Korábbi kezelés
- Prior or concurrent invasive malignancy (unless disease free > 5 years)
Egyéb
- Ductal carcinoma in situ
- Inability to safely provide sequential blood samples
- An employee who is under the direct/ indirect supervision of the principal investigator (PI)/ a co-investigator/ the study manager
- A direct study team member
- Inability to give informed consent
Kiket keres a vizsgálat
- Documented written informed consent of the participant
- Age ≥ 18 years
- Diagnosis of stage I-III breast cancer (any gender)
- Malignancy must be epithelial. Non-epithelial breast malignancies such as lymphoma or sarcoma are not allowed
- Willingness to:
- Provide blood samples
- Provide archival tumor tissue sample (only necessary for Cohort 2 if analysis of surgical tissue was not successful)
- Provide tumor tissue sample from resection/surgery (only necessary for Cohort 1 if analysis of surgical tissue was not successful)
- Permit medical record review
- Fall into one of the following categories defined below: Cohort 1, Subgroup A or B OR Cohort 2
- COHORT 1: Must have archival diagnostic tissue available
- COHORT 1: Scheduled to undergo, but has not yet begun, neoadjuvant systemic therapy followed by curative resection
- COHORT 1 (Subgroup A): HER2+ by current American Society of Clinical Oncology (ASCO)/College of American Pathologist (CAP) guidelines (any ER/PR status)
- COHORT 1 (Subgroup B): Triple negative (ER, PR and HER2 negative). Defined as ER and PR ≤ 10% by immunohistochemistry (IHC) and HER2 negative, by current ASCO/CAP guidelines
- COHORT 2: Scheduled to undergo upfront curative surgical resection with or without adjuvant chemotherapy followed by adjuvant endocrine therapy
- COHORT 2: ER+/any PR/HER2- (ER positive defined as ER > 10% by IHC)
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (5)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| City of Hope Comprehensive Cancer Center | Duarte | Egyesült Államok | Ismeretlen állapot |
| CTCA at Western Regional Medical Center | Goodyear | Egyesült Államok | Ismeretlen állapot |
| City of Hope at Irvine Lennar | Irvine | Egyesült Államok | Ismeretlen állapot |
| City of Hope Atlanta Cancer Center | Newnan | Egyesült Államok | Ismeretlen állapot |
| City of Hope at Chicago | Zion | Egyesült Államok | Ismeretlen állapot |
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