Clinical Research Directory

Effects of Negative Pressure Wound Bandaging After Mastectomy

Participant information sheet Mastectomy is a surgical method used to treat breast cancer. A mastectomy involves the removal of the entire breast. A common postoperative complication after a mastectomy is seroma, i.e. an abnormal accumulation of serous fluid in the wound cavity. At present, at Falu Lasarett, we use conventional dressings on the wound after the operation as well as an active drainage that is left in place for a couple of days. There is research that suggests that negative pressure dressings can promote wound healing and reduce the formation of seroma. The purpose of this study is to investigate whether negative pressure dressings reduce the risk of postoperative seroma compared to regular dressings. We will also look at whether it reduces the risk of other postoperative complications such as infection, bleeding and wound healing problems. We are asking all patients who will undergo a mastectomy in 2025 if they want to participate in our study. The Director of Research, Education and Innovation is the authorized representative of the research principal (which is the legal entity Region Dalarna). Research principal means the organization responsible for the project. The research is approved by the Ethics Review Authority, the registry number for the trial at the Ethics Review Authority is 2025-00006-01. How does the project work? Participating in our study means that on the day of surgery you will be randomized between two groups. One group will receive conventional wound dressings, and the other group will receive PICO negative pressure dressings. The negative pressure dressing is connected to a small canister that is worn for 7 days. Just like today, there will be a return visit to the nurse in the surgery ward after a day to check and possibly remove the active drain. There will also be a return visit to the doctor after 2-3 weeks for results of the tissue analysis and information about further treatment. The additional visit if you participate in our study is a return visit to the nurse after 7 days to remove the PICO negative pressure dressing (if you belong to that group). A return visit to the nurse is also planned after 6 months as a follow-up. If you have any questions or problems, you can contact your contact nurse. Possible consequences and risks of participating in the project The PICO negative pressure dressing is connected to a cord with a small canister that must be carried with you. The canister fits in a pocket. The canister is on 24 hours a day and emits a light vibration sound. What happens to your data? The project will collect and register information about you. Information about your medical history, measurements, medications, type of surgical procedure, number of return visits after surgery and postoperative complications will be collected from your medical record to analyze our results. The data will be pseudonymized and entered into a password-protected Excel document for analysis. The code key is stored in a lock-protected Excel file. The code key is processed so that unauthorized persons cannot access it. Your answers and your results will be processed so that unauthorized persons cannot access them. The code key and research data are stored for 10 years in accordance with research ethics because it should be possible to go back to the research data and re-analyze if question marks arise about our analysis methods. The data protection officer of Region Dalarna is responsible for your personal data. According to the EU Data Protection Regulation, you have the right to access the data about you that is handled in the project free of charge, and to have any errors corrected if necessary. You can also request that data about you be deleted and that the processing of your personal data be restricted. However, the right to deletion and restriction of processing of personal data does not apply when the data is necessary for the current research. If you would like to access the data, please contact the principal investigator (Rebecca Paul, rebecca.paul@regiondalarna.se, 023 490760). The data protection officer can be reached at dataskyddsombud@regiondalarna.se, Tel: 023-490000. If you are dissatisfied with how your personal data is processed, you have the right to file a complaint with the Swedish Data Protection Authority, which is the supervisory authority. How do you get information about the results of the project? You can access your individual data in your medical record. The results of the entire study will be reported internally at Kirurgkliniken Falu Lasarett and are intended to be published in a scientific journal. Unforeseen findings will be handled through follow-up and, if necessary, treatment. Insurance and compensation Patient insurance valid through the research principal. You will not receive compensation as the study is part of a planned procedure. Participation is voluntary.

Supporting Health Including Endocrine Treatment for Long Duration

This research is being done to pilot an intervention which aims to test a new web- and mobile application ("app")-based supportive care tool (SHIELD portal) and to assess the feasibility of enrolling female breast cancer patients with hormone receptor-positive disease long-term endocrine treatment.

Validation of the Oncoliq Test for the Early Detection of Breast Cancer.

Cancer continues to be one of the most significant public health issues worldwide. Thanks to early detection, the mortality rate of certain types of cancer has decreased significantly. However, the lack of accessible, low-cost, non-invasive, non-toxic, and easy-to-implement diagnostic methods results in late diagnoses, leading to 1 in every 6 people dying from cancer today. MicroRNAs (miRNAs) are small non-coding RNAs that regulate gene expression and are found both inside cells and in bodily fluids such as blood and urine. Several studies have demonstrated their role in human diseases, especially cancer, where tumors release miRNAs into the bloodstream that can be used as biomarkers for early detection. The research and development team at Oncoliq SAS identified a panel of miRNAs associated with breast cancer, with a detection performance of 82% sensitivity and 83% specificity, validated in exploratory and preliminary confirmatory studies. These results led to the filing of a patent based on liquid biopsy technology. The objective of this protocol is to establish a panel of miRNAs for the early detection of breast cancer using samples from breast cancer patients and a cancer-free control group. Validation of the miRNAs will be carried out through RT-qPCR. This stage constitutes the analytical validation of the biomarkers, with the goal of developing an algorithm capable of classifying individuals with and without breast cancer. In future stages, a pilot clinical trial is planned to evaluate test implementation and clinical validation.

Comparing Patient Reported Outcomes and Clinical Outcomes Based on Different Scar Placement in Patients Undergoing Standard Breast Conserving Surgery for Breast Cancer: The PROM-S Study.

This study is for patients with breast cancer and the objective is to compare patient reported outcome measures (PROMs) based on scar placement in patients undergoing standard breast-conserving surgery (sBCS). BCS has become the standard of care for eligible patients with breast cancer (current UK national BCS rate is 60%). Scar placement for sBCS can be divided into two groups: those directly over the cancer, or those in remote locations (e.g. around the nipple, near the armpit, the lower part of the breast, where the breast and the chest meet etc.) with the aim of hiding the scar in more visually acceptable locations on the breast. Multiple factors determine where the scar is placed such as aesthetics, other health conditions, location of the cancer, etc. However, it is currently unclear whether the location of scar placement for sBCS affects patient reported outcomes. The growing importance on breast cosmesis has led to more attention from clinicians and patients with regards to the selection of surgical incision placement for sBCS. By using a validated questionnaire (BREAST-Q), we wish to assess if there is any difference in PROMs based on scar placement (over the lesion vs. remote) in patients undergoing sBCS. It is anticipated that the study results will help champion and guide care for future breast cancer patients, as well as providing an insight into how patient satisfaction may vary between different sBCS approaches. This questionnaire study will include consecutive patients undergoing sBCS at Leeds Teaching Hospitals NHS Trust. Participation in this non-randomised study will not impact on routine clinical care or decision making for the type of surgery planned or scar placement choice. Patients will be asked to complete the BREAST-Q questionnaire prior to surgery, after 2 weeks, as well as 3 and 12 months after surgery.

Prospective Multicenter Single-arm Trial: AK112 + Nab-paclitaxel/Carboplatin Neoadjuvant for TNBC

This prospective, multicenter, single-arm clinical study aims to evaluate the efficacy and safety of AK112 in combination with albumin-bound paclitaxel and carboplatin as neoadjuvant treatment in adult women with early or locally advanced triple-negative breast cancer (TNBC). The study seeks to address the pathological complete response (pCR) rate, objective response rate (ORR), breast conservation rate, and invasive disease-free survival (iDFS) following treatment with AK112 combined with albumin-bound paclitaxel and carboplatin in early or locally advanced TNBC.

Effects of Two Strength Exercise Programs on Upper Limb Functionality in Breast Cancer

The goal of this experimental study is to evaluate the effect of a therapeutic exercise program based on upper limb plyometric exercises in breast cancer patients and breast cancer survivors to determine changes in upper limb functionality. The main question it aims to answer is: Does upper limb plyometric strength exercise improve upper limb dysfunctions in breast cancer patients and survivors? The researchers will compare the effects of plyometric exercise with the effects of strength training exercise to determine whether plyometric exercise improves shoulder dysfunctions in breast cancer patients and survivors. Participants from the Pontevedra group will undergo the intervention using plyometric exercise (Experimental Group), while those from the Vigo group will perform strength training exercise (Control Group). They will complete two sessions per week for six weeks. Outcome variables related to upper limb functionality will be assessed at baseline and after the intervention.