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CIPHER Study: Pilot Study to Study the Role of ctDNA in Triple Negative and HER2 Positive Early Stage
NCT05333874 · View on ClinicalTrials.gov ↗
Study Summary
Primary Objective: 1\) To examine the impact of Circulating tumor DNA (ctDNA) (expressed as mean tumor molecules per ml) on treatment decision making in patients with early stage breast cancer after neoadjuvant therapy and surgery Secondary Objectives: 1. Understand ctNDA kinetics in the neoadjuvant and adjuvant setting 2. To identify any associations between clinical staging and measurable ctDNA
Conditions Studied
Interventions
- OTHER Observational
- DRUG Neoadjuvant chemotherapy administered before surgical extraction of a tumor
Study Locations (12)
New Jersey
- Trinitas Hospital and Comprehensive Cancer Center — Elizabeth
- RWJBarnabas Health - Robert Wood Johnson University Hospital — Hamilton
- Jersey City Medical Center — Jersey City
- Monmouth Medical Center - Southern Campus — Lakewood
- Cooperman Barnabas Medical Center — Livingston
- Monmouth Medical Center — Long Branch
- Robert Wood Johnson University Hospital — New Brunswick
- Rutgers Cancer Institute of New Jersey — New Brunswick
- Newark Beth Israel Medical Center — Newark
- Robert Wood Johnson Barnabas Hospital -Somerset — Somerville
- Steeplechase Cancer Center — Somerville
- Monmouth Medical Center Vantage Point Infusion Cente — West Long Branch
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2022-04-06 |
| Est. Completion | 2027-11-28 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05333874
The ClinicalTrials.gov registry entry for NCT05333874 describes a study currently listed as active not recruiting. It is categorized as Early Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 34 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Rutgers, The State University of New Jersey, which has 603 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Breast Cancer, Early-Onset appearing as the primary indexed condition, and to 2 interventions — of which Observational is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05333874 reports 12 study locations spanning 1 distinct geographic area — top geographies include New Jersey. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05333874 about?
NCT05333874 is a clinical study titled "CIPHER Study: Pilot Study to Study the Role of ctDNA in Triple Negative and HER2 Positive Early Stage". Primary Objective: 1\) To examine the impact of Circulating tumor DNA (ctDNA) (expressed as mean tumor molecules per ml) on treatment decision making in patients with early stage breast cancer after neoadjuvant therapy and surgery Secondary Objectives: 1. Understand ctNDA kinetics in the neoadjuv...
What is the current status of trial NCT05333874?
This trial is currently active not recruiting. It is a Early Phase 1 study. The enrollment target is 34 participants. The study started on 2022-04-06. Estimated completion is 2027-11-28.
What conditions does trial NCT05333874 study?
This clinical trial studies the following conditions: Breast Cancer, Early-Onset. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05333874?
The interventions under investigation include: Observational (OTHER), Neoadjuvant chemotherapy administered before surgical extraction of a tumor (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05333874?
This trial is sponsored by Rutgers, The State University of New Jersey, which has 603 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05333874 being conducted?
This trial has 12 study locations across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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