Trial document

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DRKS-ID: DRKS00013169

Trial Description

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Title

Tattooing suspicious axillary lymph nodes in breast cancer patients treated by primary systemic therapy

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Trial Acronym

Tattoo

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URL of the Trial

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Brief Summary in Lay Language

The aim of the study is to investigate the feasibility of tattoing and identifying metastatic axillary lymph nodes in breast cancer patients receiving primary chemotherapy. Up to 74% of these patients of these patients convert to node negative after chemotherapy and in these cases complete axillary dissection is an overtreatment. Sentinel lymph node biopsy in these patients is not accuratly enough and has low detection rates. A previous study in 12 patients has shown a detection of tattowed lymph nodes after primary chemotherapy during surgery in all cases (Choy et al. 2015). This result has to be proved in a larger number of patients. All breast cancer patients treated at the university of Rostock receiving primary chemotherapy without distant metastases can be paticipants of this trial. In these patients higly purifid carbon solution is injected into the suspicious axillary lymphnode, which we hope to find easily during surgery.

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Brief Summary in Scientific Language

The aim of the study is to investigate the feasibility of tattoing and identifying metastatic axillary lymph nodes in breast cancer patients receiving primary systemic therapy. Up to 74% of these patients of these patients convert to node negative after chemotherapy and in these cases complete axillary dissection is an overtreatment. SLNB in these patients has unacceptable false-negative rates and clip-marked lymph nodes have low detection rates. A previous study in 12 patients has shown a detection of tattowed lymph nodes after primary systemic therapy during surgery in all cases (Choy et al. 2015).
Amendment 1 18.04.2018: number of patients n=100, multicentric study

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

DRKS-ID: DRKS00013169
Date of Registration in DRKS: 2017/10/24
Date of Registration in Partner Registry or other Primary Registry: [---]*
Investigator Sponsored/Initiated Trial (IST/IIT): yes
Ethics Approval/Approval of the Ethics Committee: Approved
(leading) Ethics Committee No.: A 2017-0142, Ethik-Kommission an der Medizinischen Fakultät der Universität Rostock

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Secondary IDs

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Health Condition or Problem studied

Free text: breast cancer
ICD10: C50 - Malignant neoplasm of breast

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Interventions/Observational Groups

Arm 1: 14G-Core needle biopsy and tattoing (highly purified carbon solution: 0,1-0,5ml Spot) of the largest suspicious axillary under ultrasound guidance and documentation prior primary systemic therapy

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Characteristics

Study Type: Interventional
Study Type Non-Interventional: [---]*
Allocation: Single arm study
Blinding: Open (masking not used)
Who is blinded: [---]*
Control: Uncontrolled/Single arm
Purpose: Treatment
Assignment: Single (group)
Phase: N/A
Off-label Drug use: N/A

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Primary Outcome

detection rate of charcoal tattoed metastatic axillary lymph nodes during surgery after primary systemic therapy in breast cancer patients

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Secondary Outcome

- concordance of SLN and tattooed LN
- predictive value of tattoed LN for residual metastatic disease in other axillary lymph nodes
- complications caused by tattoing axillary lymph nodes (regarding injection until surgery)

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Countries of Recruitment

DE: Germany
SE: Sweden

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Locations of Recruitment

University Medical Center Rostock
Stockholm, Esslingen

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Recruitment

Planned/Actual: Actual
(Anticipated or Actual) Date of First Enrollment: 2017/11/07
Target Sample Size: 100
Monocenter/Multicenter trial: Multicenter trial
National/International: International

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Inclusion Criteria

Gender: Female
Minimum Age: 18 Years
Maximum Age: no maximum age

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Additional Inclusion Criteria

All patients with primay breast cancer (c/iT1-T4c, uni- or bilateral) diagnosed at the university of Rostock, treated by primary systemic therapy presenting with suspicious axillary lymph nodes (c/i N+) without distant metastases.

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Exclusion Criteria

- male patients
- pregnancy
- age < 18 Years
- distant metastases
- no informed consent

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Addresses

Primary Sponsor
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- Universitätsfrauenklinik Rostock
- Südring 81
- 18059 Rostock
- Germany
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- Telephone: [---]*
- Fax: [---]*
- E-mail: [---]*
- URL: [---]*
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Contact for Scientific Queries
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- Universitätsfrauenklinik Rostock
- Ms. Dr. med. Steffi Hartmann
- Südring 81
- 18059 Rostock
- Germany
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- Telephone: 0381/44014500
- Fax: [---]*
- E-mail: steffi.hartmann at kliniksued-rostock.de
- URL: [---]*
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Contact for Public Queries
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- Universitätsfrauenklinik
- Ms. Dr. med. Steffi Hartmann
- Südring 81
- 18059 Rostock
- Germany
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- Telephone: 0381/44014500
- Fax: [---]*
- E-mail: steffi.hartmann at kliniksued-rostock.de
- URL: [---]*
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Sources of Monetary or Material Support

Institutional budget, no external funding (budget of sponsor/PI)
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- Universitätsfrauenklinik Rostock
- Südring 81
- 18059 Rostock
- Germany
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- Telephone: [---]*
- Fax: [---]*
- E-mail: [---]*
- URL: [---]*
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Status

Recruitment Status: Recruiting complete, follow-up complete
Reason, if "Recruitment stopped after recruiting started" or "Recruiting withdrawn before recruting started": [---]*
Reason, if Reason for Recruiting Stop "Other": [---]*
Study Closing (LPLV): 2020/04/15
Number of Participants in Germany after Recruiting complete: 85
Total Number of Participants (all Sites worldwide) after Recruiting complete: 117

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Trial Publications, Results and other Documents

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