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NCT01836640 · ClinicalTrials.gov registry record
Developing Plasma DNA as a Surrogate for Tumor Biopsy to Identify Tumor Genetic Alterations in Patients With Advanced Breast Cancer
A clinical trial, sponsored by Dartmouth-Hitchcock Medical Center.
- Terminated
- Registry status
- 9
- Enrollment target
NCT01836640: Clinical Trial study, sponsored by Dartmouth-Hitchcock Medical Center.
NCT01836640 is a clinical trial that was terminated before completion, run by Dartmouth-Hitchcock Medical Center. The registered enrollment target is 9 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01836640 was terminated before completion, sponsored by Dartmouth-Hitchcock Medical Center.
- TERMINATED
- Registry status
- 9 participants
- Enrollment target
Study Summary
There are three major subtypes of breast cancer: 1. Hormone receptor positive (contain cells that express the estrogen receptor or progesterone receptor). 2. Tumors that express the epidermal growth factor receptor gene ( HER-2) 3. Triple negative (cancer cells that lack the hormone receptors and the epidermal growth factor receptor gene HER-2. While effective therapies exist for most cases of breast cancer at first occurrence, many patients eventually exhibit disease that does not respond to all standard breast therapies, particularly in the metastatic setting. There are therapies that are used to treat other types of cancers with genetic mutations that are in the process of being evaluated for use in breast cancer. The current techniques used for detecting mutations in the genes of breast cancer patients, which can be treated with drugs specific for the genetic mutations, are invasive and identifying effective diagnostic non-invasive procedures are the next challenge for physicians. This study will compare the ability to detect genetic mutations samples from non-invasive procedures such as a blood draw, to more invasive procedures such as tissue taken from a biopsy sample. There is also a concern with current techniques used to detect genetic mutations that cells from a single tissue sample may not be representative of the types of cells present in all the tumors in the body and therapies selected using a single tissue sample may not be effective for all of the cancer in the body. This study will use blood drawn from participants prior to any drug therapy and compare the genes from this blood to tissue samples from multiple sites of disease. The study will also compare the genetic profile of the metastatic tumors to the genetic profile of the original breast cancer to determine if there are any changes in the genetics of the tumor cells. The participants that have newly diagnosed metastatic disease will provide tissue from their primary site of disease via a
Primary Outcome
To determine whether the genetic mutations in plasma DNA are reflective of the genetic mutations present in biopsies of tumor tissue obtained from ≥ 3 tumors within patients with metastatic breast cancer.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2013-12 |
| Est. Completion | 2016-04 |
Why NCT01836640 stopped before completion
NCT01836640 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 9 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT01836640 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01836640 about?
NCT01836640 is a clinical study titled "Developing Plasma DNA as a Surrogate for Tumor Biopsy to Identify Tumor Genetic Alterations in Patients With Advanced Breast Cancer". There are three major subtypes of breast cancer: 1. Hormone receptor positive (contain cells that express the estrogen receptor or progesterone receptor). 2. Tumors that express the epidermal growth factor receptor gene ( HER-2) 3. Triple negative (cancer cells that lack the hormone receptors and t...
What is the current status of trial NCT01836640?
This trial is currently terminated. The enrollment target is 9 participants. The study started on 2013-12. Estimated completion is 2016-04.
Who is sponsoring clinical trial NCT01836640?
This trial is sponsored by Dartmouth-Hitchcock Medical Center, which has 427 total clinical trials registered on ClinicalTrials.gov.
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