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NCT05333874 · ClinicalTrials.gov registry record · Early Phase 1
CIPHER Study: Pilot Study to Study the Role of ctDNA in Triple Negative and HER2 Positive Early Stage
A Early Phase 1 study of Breast Cancer, Early-Onset, sponsored by Rutgers, The State University of New Jersey.
- Active
- Registry status
- Early Phase 1
- Development phase
- 34
- Enrollment target
- 12
- Study locations
NCT05333874: Active Early Phase 1 study of Breast Cancer, Early-Onset, sponsored by Rutgers, The State University of New Jersey.
NCT05333874 is a Early Phase 1 study of Breast Cancer, Early-Onset that is active but no longer recruiting, run by Rutgers, The State University of New Jersey. The registered enrollment target is 34 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (36% lower). The trial reports 12 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05333874, a Early Phase 1 study of Breast Cancer, Early-Onset, is active but no longer recruiting, sponsored by Rutgers, The State University of New Jersey.
- ACTIVE NOT RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 34 participants
- Enrollment target
- 12
- Study locations
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
Primary Outcome
Participants with detectable ctDNA fourteen days post-operatively will have the option to change adjuvant therapy after discussion with primary provider. SignateraTM is intended to detect and quantify how much cancer is left in the body, to improve prognosis and help optimize treatment decisions, based on the tissue-informed testing of mutations.
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 |
What the registry record for NCT05333874 still lists
NCT05333874 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (36% lower).
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.
NCT05333874 lists 12 locations in 1 state (New Jersey).
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.
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).
Who is sponsoring clinical trial NCT05333874?
This trial is sponsored by Rutgers, The State University of New Jersey, which has 413 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT05333874's enrollment target sits among peer trials
34 748th of 2000 higher than 1,239 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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